Psychosocial functioning among current noninjecting opioid users: Is there any difference between methadone maintenance treatment and treatment as usual?

Background: Patients with opioid use disorder (OUD) have a significant problem in psychosocial functioning domains, which are not systematically studied in India. This study aimed to evaluate the psychosocial functioning in current noninjecting opioid users on Methadone Maintenance Treatment (MMT) versus Treatment as Usual (TaU: Chlordiazepoxide, Zolpidem, Trazodone, Tramadol, Tapentadol, and Buprenorphine). Materials and
Methods: It is a cross-sectional study on patients of current noninjecting OUD on MMT or TaU for at least in the past month. Comorbidities and illness severity were assessed with the help of Mini-International Neuropsychiatric Interview 7.0.2 and World Health Organization-The Alcohol, Smoking, and Substance Involvement Screening Test 3.0, respectively. Social and occupational functioning assessment scale (SOFAS), WHO Quality of Life (WHOQoL-BREF), and Client Satisfaction Questionnaire (CSQ-8) assessed the sociooccupational functioning and QoL and client satisfaction. A total of 67 participants (37 on MMT and 30 on TaU) were included in the study.
Results: A significant difference between the two groups (MMT better than TaU) was based on SOFAS scores, CSQ-8, and WHOQoL-BREF. In the TaU group, there was a significant negative correlation between risk of addiction severity with sociooccupational functioning (r = -0.5; P = 0.0046), physical health (r = -0.48; P = 0.0087) and social relationship (r = -0.47; P = 0.0087) domain of QoL. In the MMT group, the association between risk of addiction severity with sociooccupational functioning, domains of QoL, and client satisfaction were insignificant.
Conclusion: Sociooccupational Functioning, Client Satisfaction, and QoL of patients maintained on MMT are better than those on TaU. Copyright:

INTRODUCTION

Opioids form a complicated class among the available illegal substances. As per the World Drug Report 2020, in the year 2018, there were 57.8 million opioid users, globally of which more than half were on opiates.[1] Approximately 20% of the global opioid users reside in south Asia.[1] The global estimate suggests that, between 2008 and 2017, there has been a 28% increase in disability-adjusted life years and a 71% increase in deaths due to opioid use disorders (OUDs).[1] If the Indian figures are taken into account, about 0.7% of the general population is abusing opioids that correspond to 2 million current opioid users, and 0.5 million opioid-dependent people and about 177,000 people use opioids through injectable route.[2] The subset of opioid users in India’s substance-using population primarily uses it through noninjectable routes, while all those People Who Inject Drugs (PWIDs) show the use of opioid injections most of the time.[3] Noninjectable use forms part of the early phase after the onset of illness in most of the PWIDs,[3] and it takes about 2–10 years in transition from noninjecting use to injecting use. Noninjectable forms are commonly tramadol, dextropropoxyphene, codeine, buprenorphine, and heroin. Individuals using opioids with high dependence potential (e.g., heroin) mostly require substitution therapy.

Studies have demonstrated that quality of life (QoL) is compromised in individuals with OUD, and it has an association with socioeconomic status, residential conditions, familial disputes, sex, literacy levels, HIV status, and presence of medical and psychiatric comorbidities.[4] Furthermore, an improvement in QoL has been observed using the short-term (up to 6 months) and long-term (6 months to 3 years) opioid substitution therapy (OST). Even among the available OST medications, methadone shows an earlier onset, better health-related outcomes, and cost-effectiveness than buprenorphine.

OUD, being a highly addictive disorder, is likely to affect social functioning adversely. Social functioning can be understood as the capacity to accomplish the obligations, needs, expectations, and manage interpersonal relationships and that functional impairment correlates with a compromised QoL, unemployment, and relational problems in early phases of illness in young psychiatric patients. Stigma and poor psychosocial support associated with OUD are also expected to influence psychosocial functioning largely.

The existing treatment protocols/programs for OUD provide varying degrees of satisfaction (clients). Client Satisfaction provides information about the patient’s opinion about the program and patient–clinician interactions which help researchers in ascertaining the treatment-related experiences and requirements.[5] A study done in Baltimore found that client satisfaction related to methadone treatment was prognosticative of treatment retention independent of the severity of dependence. A California-based study revealed that satisfaction correlated positively with treatment completion and duration of treatment retention.[6]

Methadone maintenance treatment (MMT) has recently been introduced in India and is slowly expanding across the nation. However, it has not been researched much in India. Evidence from international studies suggests that MMT is an effective treatment modality for OUDs. There is a skeptical attitude of society, government, media, and even the medical professionals toward OST (i.e., toward replacement with buprenorphine, methadone, and tramadol), in India.[2] To note here, buprenorphine, methadone, and tramadol are used in the short-term treatment as well as in the maintenance treatment of OUDs in India.[27] Similarly, the patients’ and their carers’ logistic problems to visit a hospital every day to receive the doses of methadone under supervision is again a challenging and probably stigmatizing phenomenon. This study intended to evaluate the clinical profile and psychosocial functioning as the QoL, sociooccupational functioning, and client satisfaction in current noninjecting opioid users on MMT versus those on treatment as usual (TaU) and compare the association of various sociodemographic and clinical variables with factors mentioned above in the above two groups of opioid users. We hypothesized that the patients on MMT would have better psychosocial functioning compared to those on TaU.

MATERIALS AND METHODS

The present study is a cross-sectional comparative study conducted in the department of psychiatry of a tertiary care teaching hospital in North India. The study was approved by the institutional ethics committee (Ref. code: 93rd ECM II B-Thesis/P48). It involves studying clinical profile and psychosocial functioning as the QoL, sociooccupational functioning, client satisfaction in patients of current noninjecting OUDs on MMT, and TaU. Purposive sampling was used for recruitment of the patients.

For this study, the term “TaU” was operationally defined as the treatment conventionally prescribed (e.g., Buprenorphine, Tramadol, Tapentadol, Benzodiazepines, and Clonidine) in the outpatient department (OPD) to the patients with OUD for the management of withdrawal symptoms and subsequent relapse prevention. Many of these medications are also used during the maintenance phase of treatment due to the nonavailability of methadone over the counter in India. In the study, TaU is referred to the use of treatment conventionally prescribed (e.g., Buprenorphine, Tramadol, Tapentadol, Benzodiazepines, and Clonidine) during the maintenance phase of OUD treatment. As methadone is not a routine treatment (due to limited availability) in most of the centers of India, it was considered as a different group.

Patients with an age of 18 years and above, attending de-addiction OPD, Adult Psychiatry OPD and Drug Treatment Centre of Department of Psychiatry of a tertiary care teaching hospital of North India and having a diagnosis of OUD as per Diagnostic and statistical manual of mental disorders-5th edition, using the noninjecting form of opioids currently and maintained on MMT and TaU for at least past 1 month, with a Clinical Opiate Withdrawal Scale score <5 were taken up for the study. As this was a time-bound study, we took the minimum duration, for which the patient should remain in stable dose of medication with adequate control of their withdrawal symptoms, as 1 month, according to previous research.[8] Current noninjecting opioid users are defined as those individuals who have not used any psychoactive substance by injectable route for nonmedical reasons at any time over the past 3 months (irrespective of their past injectable opioid use). This definition is based on the views of experts working in the field of IDU in India and is in line with the concept of Injecting Drug Users defined in the National AIDS TAU GROUP Programme Guidelines on OST.[9] Those on MMT formed the case group, while those on TaU formed the control group. Both the groups were receiving maintenance treatment for OUD after adequate control of their withdrawal symptoms.

Those patients, who did not adhere to the prescribed treatment regime, qualified for other substance use disorders (except tobacco use disorder) during the past 1 year, with injectable drug use irrespective of the nature of the substance and had significant medical morbidity that required priority medical management and made assessment difficult were excluded from the study. Patients receiving MMT were recruited from Drug Treatment Centre of Department of Psychiatry of a tertiary care teaching hospital, where the treatment was dispensed daily under supervision of a dedicated doctor and staff. Patients receiving TaU were recruited from de-addiction OPD, Adult Psychiatry OPD, where the consultation is provided by the consultant psychiatrist and postgraduate residents of psychiatry. Inpatient care is offered to both the groups of patients; however, to keep the groups homogeneous, we recruited patients from outpatient settings, whose withdrawal symptoms were well managed and they were on maintenance treatment. None of the patients were receiving any active psychosocial/family intervention at the time of recruitment to the study, as it may influence the outcome of the study.

Written informed consent was obtained from the patients before enrollment in the study. Sociodemographic and clinical details were recorded in a predesigned semi-structured pro forma. Mini-International Neuropsychiatric Interview 7.0.2 was applied to assess comorbid psychiatric illness and substance use disorder.[10] The Hindi version of the World Health Organization-The Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST 3.0) was administered to assess the risk and severity of the level of use.[11] Clinical variables such as age of onset of illness, the total duration of illness, duration of untreated illness, duration of MMT/TaU, and comorbidities (medical/psychiatric) were documented for the study. Psychosocial functioning was studied as sociooccupational functioning, client satisfaction, and QoL. The social and occupational functioning assessment scale (SOFAS) was applied to assess sociooccupational functioning.[12] Assessment of QoL was done using the WHO QoL (WHO QoL-BREF) Scale.[13] The satisfaction of the client was rated on the Client Satisfaction Questionnaire (CSQ-8).[14] All the above used tools were validated in Indian population and were used in several Indian studies in the past.[151617] The questionnaires were administered in Hindi. It was followed by analyzing the clinical variables and sociodemographic variables concerning the psychosocial functioning in both groups.

Statistical analysis

Statistical analysis was done using Graph Pad Quick Calcs online version (https://www.graphpad.com/quickcalcs/contMenu/). For statistical significance, the P value is considered to be <0.05. The sociodemographic and clinical variables were compared between the TaU and MMT groups using the Chi-square test and student’s t-test. Similarly, the outcome variables (client satisfaction, sociooccupational functioning, and QoL) were compared using a Student’s-t-test. Correlational analysis was done between the clinical and outcome-variables by Pearson’s correlation analysis.

RESULTS

A total of 53 patients on MMT and 53 patients with TaU were screened, of which 37 patients with MMT and 30 patients with TaU met the selection criteria, hence included in the study. In both groups, comorbid other substance use disorders were the primary reasons for exclusion, followed by nonwillingness to participate in the study.

Table 1 shows the sociodemographic profile of cases (MMT group) and controls (TaU group). The differences in the sociodemographic variables between the two groups are not significant. In the TaU group, 14 patients were on chlordiazepoxide, 10 patients were on zolpidem, 10 patients were on trazodone, 8 patients were receiving tramadol, 8 patients were on tapentadol, 3 patients were on buprenorphine, and one patient was on clonidine. The number of ever injectable users in the MMT and TaU group were 7 (18.9%) and 4 (13.33%), respectively.

Table 1

Sociodemographic profile of study sample

	Frequency (%)		Tests of significance
	MMT group (n=37)	TaU group (n=30)
Age (years)*
18-25	7 (18.90)	6 (20)	χ2=3.3574 P=0.4999
26-35	14 (37.84)	11 (36.67)
36-45	7 (18.90)	10 (33.33)
46-55	5 (13.51)	2 (6.67)
56-65	4 (11.43)	1 (3.33)
Mean age±SD (years)**	36.68±12.31	34±9.53	T=0.9778 df=65 P=0.3318
Education (years)*
0-5	9 (24.32)	2 (6.67)	χ2=4.0546 P=0.1317
6-10	16 (43.24)	14 (46.67)
>11	12 (32.43)	14 (46.67)
Income (in Rs./month)*
<10,000	17 (45.95)	14 (46.66)	χ2=1.4974 P=0.4729
10,000-20,000	14 (37.84)	8 (26.67)
>20,000	6 (16.22)	8 (26.67)
Religion*
Hindu	31 (83.78)	24 (80)	χ2=0.1613 P=0.6879
Non-Hindu	6 (16.22)	6 (20)
Family structure*
Joint	16 (43.24)	13 (43.33)	χ2=0.0001 P=0.9941
Nuclear	21 (56.76)	17 (56.67)
Domicile*
Urban	30 (81.1)	21 (70)	χ2=1.1191 P=0.2901
Rural	7 (18.92)	9 (30)
Gender*
Male	37 (100)	28 (93.33)	N/A
Female	0	2 (6.66)
Marital status*
Married	22 (59.46)	19 (63.33)	χ2=0.1047 P=0.7463
Single (unmarried/divorced/separated/widow)	15 (40.54)	11 (36.67)
Occupation*
Unemployed	1 (2.70)	4 (13.33)	χ2=8.9121 P=0.1786
Unskilled	10 (27.02)	3 (10)
Semiskilled	9 (24.32)	3 (10)
Skilled	4 (10.81)	6 (20)
Farmer	3 (8.11)	5 (16.67)
Semi-professional	7 (18.92)	6 (20)
Professional	3 (8.11)	3 (10)

*Chi-square test, **Unpaired t-test. MMT – Methadone maintenance treatment; TaU – Treatment as usual; SD – Standard deviation

Table 2 shows that a statistically significant difference is present between the MMT group and TaU group in terms of the total duration of illness and duration of untreated illness.

Table 2

Comparison of clinical variables between methadone maintenance treatment group and treatment as usual group

Clinical variables	Mean value±SD		Test of significance (unpaired t-test)
	MMT group (n=37)	TaU group (n=30)
Age of onset (years)	25.97±7.99	28.55±8.41	T=1.2822 df=65 P=0.2043
Total duration of illness (years)	10.59±10.55	4.83±4.49	T=2.7889 df=65 P=0.0069
Duration of untreated illness (years)	9.13±9.81	4.61±4.44	T=2.3347 df=65 P=0.0227
Duration of MMT/TaU (months)	2.81±1.91	2.08±1.49	T=1.7065 df=65 P=0.0927

MMT – Methadone maintenance treatment; TaU – Treatment as usual; SD – Standard deviation

The frequency distribution of the presence or absence of comorbidities in the MMT group and TaU group was also compared, which did not show any significant difference between the two.

Table 3 shows the comparison of scores of SOFAS, WHO ASSIST, CSQ-8, and WHO-QoL-BREF between the MMT group and TaU group.

Table 3

Comparison of psychosocial functioning between methadone maintenance treatment group and treatment as usual group

Score on SOFAS
Score	Frequency (%)		Test of significance
	MMT group (n=37)	TaU group (n=30)
61–70	6 (16.22)	14 (46.66)	χ2=7.7955 P=0.0203
71–80	16 (43.24)	10 (33.33)
81–90	15 (40.54)	6 (20)
Mean score±SD**	78.95±8.01	73.33±6.73	T=3.0610 df=65 P=0.0032
Scores on WHO ASSIST
	MMT group (n=37)	TaU group (n=30)	Test of significance
Mean score	21.68±10.74	26.06±9.33	T=1.7590 df=65 P=0.0833
Score on CSQ-8
	MMT group (n=37)	TaU group (n=30)	Test of significance
Mean score	21.43±1.43	20.56±1.52	T=2.3964 df=65 P=0.0194
Scores on WHO QoL-BREF
Domains	Mean score±SD		Test of significance
	MMT group (n=37)	TaU group (n=30)
Physical health	70.08±12.03	49.97±20.04	T=5.0819 df=65 P=<0.0001
Psychological health	72.68±12.69	56.70±20.78	T=3.9034 df=65 P=0.0002
Social relationships	65.19±20.17	48.07±23.56	T=3.2024 df=65 P=0.0021
Environment	74.38±12.89	58.37±14.63	T=4.7606 df=65 P=<0.0001

SOFAS – Social and Occupational Functioning Assessment Scale; CSQ – Client satisfaction questionnaire-8; WHO – World Health Organization; QoL – Quality of life; ASSIST – Alcohol, smoking, and substance involvement screening test; MMT – Methadone maintenance treatment; TaU – Treatment as usual; SD – Standard deviation

The mean score of WHO-ASSIST among the MMT group was 21.68 ± 10.74. The mean score of WHO-ASSIST among the TaU group was 26.06 ± 9.33, with no significant difference between the MMT group and TaU group based on frequency distribution or the total scores. The frequency distribution based on WHO-ASSIST scores shows that, among MMT patients, 59.46% fall in the moderate-risk group (4–26), while 63.33% of TaU patients fall under the high-risk group (27+).

Assessment of the sociooccupational functioning of the MMT group and TaU group was done on SOFAS. Among the MMT group, 83.78% fall in the score range of 71–90. Among the TaU group, 79.99% fall in the score range of 61–80. The mean score of SOFAS among the MMT group was 78.95 ± 8.01. The mean score of SOFAS among the TaU group was 73.33 ± 6.73. A significant difference was present between the groups based on frequency distribution and mean scores of SOFAS.

The mean score of CSQ among the MMT group was 21.43 ± 1.43, and the mean score of CSQ among the TaU group was 20.56 ± 1.52, with a significant difference being present between the two groups.

Comparison of quality-of-life domains assessed on WHOQoL-BREF revealed a significant difference in the mean scores of the two groups in all the domains of WHOQoL-BREF.

Correlations were analyzed between psychosocial functioning (WHOQoL-BREF, SOFAS, CSQ-8) and the clinical variables in both groups [Table 4]. A statistically significant negative correlation was found between the age of onset and physical health among the MMT group and between the duration of TaU and psychological health in the TaU group. The correlation between the duration of treatment and client satisfaction in the MMT group (r = 0.072; P = 0.672) and TaU group (r = −0.293; P = 0.116) were insignificant. Similarly, the correlation between the duration of treatment and sociooccupational functioning in the MMT group (r = −0.187; P = 0.268) and TaU group (r = −0.336; P = 0.069) were insignificant.

Table 4

Correlation between World Health Organization - alcohol, smoking, and substance involvement screening test Scores and scores on domains of World Health Organization quality of life - Bref, Social and Occupational Functioning Assessment Scale, client satisfaction questionnaire with clinical variables between methadone maintenance treatment group and treatment as usual group

Domains of WHOQoL-BREF	MMT group (n=37)		TaU group (n=30)
	Age of onset	Duration of treatment	Age of onset	Duration of treatment
Physical health
r	−0.3928	−0.0483	−0.1895	−0.3492
P	0.0164	0.7779	0.3172	0.0587
Psychological health
r	−0.2217	−0.2122	−0.1490	−0.5339
P	0.1907	0.2078	0.4606	0.0024
Social relationship
r	−0.0544	−0.0905	0.1285	−0.2660
P	0.7509	0.5963	0.4986	0.1554
Environment
r	−0.2196	−0.1978	−0.0055	−0.3380
P	0.1928	0.2600	0.9791	0.0749
SOFAS
r	−0.1360	−0.1873	−0.0393	−0.3365
P	0.4222	0.2676	0.8378	0.0694
CSQ-8
r	−0.0087	0.0719	−0.2013	−0.2933
P	0.9625	0.6724	0.2893	0.1161

SOFAS – Social and Occupational Functioning Assessment Scale; CSQ – Client satisfaction questionnaire-8; WHO QoL – World Health Organization quality of life; MMT – Methadone maintenance treatment; TaU – Treatment as usual

Correlations were analyzed between psychosocial functioning (WHOQoL-BREF, SOFAS, CSQ-8) and the WHO-ASSIST score in both groups [Table 5]. Significant negative correlation was found between WHO ASSIST score with the physical health, social relationship domain of QoL, and SOFAS scores in the TaU group.

Table 5

Correlation between World Health Organization - alcohol, smoking, and substance involvement screening test Scores and scores on domains of World Health Organization quality of life - BREF, Social and Occupational Functioning Assessment Scale, client satisfaction questionnaire and duration of treatment between methadone maintenance treatment group and treatment as usual group

Domains of WHOQOL-BREF	MMT group (n=37)	TaU group (n=30)
Correlation with WHO-ASSIST scores
Physical health
r	−0.1713	−0.4791
P	0.3116	0.0087
Psychological health
r	−0.2819	−0.2994
P	0.0920	0.1201
Social relationship
r	−0.0152	−0.4747
P	0.9297	0.0087
Environment
r	−0.1935	−0.2255
P	0.2524	0.2319
SOFAS
r	−0.2563	−0.5033
P	0.1356	0.0046
CSQ
r	−0.2429	−0.3473
P	0.1490	0.0603
Duration of treatment
Correlation with SOFAS
r	−0.187	−0.336
P	0.268	0.069
Correlation with CSQ
r	0.072	−0.293
P	0.672	0.116

SOFAS – Social and Occupational Functioning Assessment Scale; CSQ – Client satisfaction questionnaire-8; WHO – World Health Organization; QoL – Quality of life; ASSIST – Alcohol, smoking, and substance involvement screening test; MMT – Methadone maintenance treatment; TaU – Treatment as usual

DISCUSSION

The present study is a cross-sectional, comparative study conducted on patients with OUD over approximately 1 year at a tertiary care center in North India. Noninjectable opioid users have been taken up in the present study, as such patients’ profile is completely different, and they often have several medical comorbidities that impair their QoL. Several Indian studies reported that the sociodemographic and clinical profile of opioid users vary according to the nature, form, mode, and duration of use of opioids.[1819] Hence, to minimize the confounding factors, we attempted to keep the patient groups uniform in their opioid use characteristics (by taking noninjecting OUD both in TaU and MMT groups). Noninjectable use, forms the part of the early phase after onset of illness in most of the PWIDs[3] and it takes about 2–10 years in transition from noninjecting use to injecting use. Evidences support that about 1–5 years elapse between switching from noninjecting to injecting opioid use practice.[320] This suggests that the population of noninjecting opioid users form a significant chunk of the overall opioid users present in the nation. Hence, interventions focused on noninjecting users during the primordial stages of illness could curb further complications which may arise out of the ensuing injectable opioid use.[3] However, mostly strategies such as those aiming to prevent HIV transmission target PWIDs neglecting the roots, i.e., the noninjectable users, from where the illness arose. This can prove to be a hurdle in the effective treatment of the condition.

Methadone maintained individuals in the present study show a significantly better functioning than the TaU. Similarly, the most patients on TaU were having high risk in comparison to MMT group, where most patients had moderate risk of addiction (as per WHO ASSIST score). It can be accounted for, based on the intrinsic properties of methadone (full agonist of m-opioid receptors). The drugs used as TaU are often less potent and less agonistic activity at the opioid receptors than methadone. Patients on MMT are also provided with psychosocial interventions and referral services (for medical comorbidities) holistically.

Studies suggest that substance use disorder is associated with poor social and occupational functioning, which is believed to be a function of psychological and physical health, interpersonal and family relationships, education, duration and severity of substance use, and degree of stigma and discrimination experienced in the society[2122] as well as the associated neurobiological changes.[23] A Cochrane review made by Mattick et al. in 2009 suggested that methadone was more efficacious than nonpharmacological treatment in retaining patients and in decreasing the use of heroin.[24]

Client satisfaction was higher among MMT patients than TaU patients. Literature review suggests that client satisfaction is a broad term that encompasses the effect of a multitude of factors such as clients’ opinion of the program environment, client–clinician intercommunication, views of clients receiving treatment services, client attributes, duration of treatment, history of drug use, and educational background[5] along with the mental health and social functioning of the client. Considering the findings of this study, we can say that methadone-maintained patients seemed more satisfied, which may be related to their perceived improvement in physical and psychological symptoms because of the full-agonistic activity of methadone. Furthermore, increased contact time with the service providers with regular monitoring of symptoms, provision of free counseling services, frequent and convenient discussions between the patient and service providers, regular reassurances and psychoeducation about the illness, free of cost medications, and referral services account for the better client satisfaction in this group.[25] Furthermore, the higher prevalence of comorbidities in TAU accounted for the lower client satisfaction in this group.

There is a significant difference between the groups on the basis of domain scores of WHOQoL-BREF, i.e., on the basis of QoL Scores we can say that patients on methadone are better than those on “TaU.” The reasons stand clear. First, there is a difference in the chemical nature of methadone and “TaU” drugs. Methadone’s full agonism at mu opioid receptors, slow onset and a long duration of action, a safe oral route of administration ensure a better coverage of the symptoms of illness throughout the day. Drugs forming the “TaU” group provide symptom specific relief for a shorter period of time after administration and need to be ingested frequently during the day time. It helps in enhancing the functioning of individuals. Second, methadone is available absolutely free of cost from the OST centers while procuring the “TaU” drugs need expenditure being done on part of the patient. The search for money to obtain drugs led to the legal issues, so the use of a drug available free of cost leads to a decline in criminality and hence less reported legal issues. Third, OST centers also provide psychosocial assistance to the patients which addresses their problematic lifestyles and also the physical, mental, social and occupational impairments. It ensures patient retention in treatment and decreases drop-out and helps in rehabilitation of the patient. Fourth, the staff at OST centers is trained to hold a positive attitude toward patients which is opposite to the negative opinions and stigma, the patients have faced all through their lives. It gives a confidence and motivational boost to the patient to continue with OST. Fifth, even if the patients use substance while on treatment they are not punished, instead attempts to identify the cause for this lapse and strengthening of patient’s motivation to quit is done. Finally, the approach is tailored to the needs of individual patients. Overall, the benefits are manifold.

Methadone-based services play an important role in improving life quality.[26] Many other studies support the superiority of methadone in the treatment of OUD compared to those who don’t receive any treatment or on other pharmacological management modalities (TaU, buprenorphine, etc.,).[27282930] There were some paradoxical findings such as significant negative correlation of age of onset of opioid use and current physical health in MMT group, though there was no significant correlation with other domains of QoL. This finding might be due to improved current physical health of the patients due to enrollment in MMT irrespective their age of onset.

Strengths

This is the first study of this kind in India that compared patients on MMT with TaU. The Stringent selection criteria used in the study help in interpreting results with certainty.

Limitations

However, as the cross-sectional study was of small sample size and recruited patients from a single tertiary care center, which could have led to difficulty in extrapolating the results of the study to the community hence limiting the power of the study. The need is to conduct prospective studies taking larger sample sizes with appropriate matching of baseline variables may help to understand the situations for better application of knowledge. As this is a cross-sectional study and the patients were already on therapy, randomization was not possible. The two groups’ baseline characteristics (particularly, their psychosocial variables) were not matched strictly, which may be responsible for differences in outcomes. The demography-related confounders have not been controlled. Similarly, short treatment period and lack of baseline data, personality, motivation, and attitudinal factors in both the groups may be possible limiting factors in this study. Selection biases might have been one of the possible explanations (methadone being given to those who were willing to come daily). The prepost QOL would have been useful in clarifying, but the cross-sectional structure of the study does not allow for this. Another potential limiting factor would be nonblinding of assessors. Future research with strict baseline matching for sociodemographic and clinical variables (though challenging to do) may give better insight into the beneficial role of MMT. The findings of the study need to be interpreted considering the fact that the psychosocial supports and other ancillary care provided by the health-care facilities as well as the cooperation and attitude of the caregivers also influence the QoL and satisfaction of the clients. There are variations in the above codeterminants across various health-care settings and geographical regions. Hence, the findings of this study may not be exactly relevant to all these settings.

Recommendations

A prospective study, with random recruitment of participants into two groups and serial assessment of psychosocial functioning, may give better insight, which will help in understanding the relevance in long-term care. As MMT is associated with better psychosocial functioning, the government should expand the program for dispense of methadone in the community setting on a large scale. Expansion of the MMT program may facilitate care to patients with current noninjectable opioid users including oral opioid users, too.

CONCLUSION

This study demonstrated that the sociooccupational functioning, client satisfaction, and QoL of patients receiving MMT are significantly better than that of patients on TaU. There is a need of more research involving multiple centers and larger population with better study design for better replicability of the findings. It needs to be implemented on a large scale for better treatment adherence and outcome, considering all the possible biases.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.