Kimberly Goodyear1,2,3, Talia R Vasaturo-Kolodner1,4, George A Kenna2, Robert M Swift2,5, Lorenzo Leggio1,3,5,6,7,8, Carolina L Haass-Koffler1,2,3. 1. Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. 2. Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Providence, RI, USA. 3. Clinical Psychoneuroendocrinology and Neuropsychopharmacology, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore and Bethesda, MD, USA. 4. Department of Neuroscience, Brown University, Providence, RI, USA. 5. Veterans Affairs Medical Center, Providence, RI, USA. 6. Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. 7. Division of Addiction Medicine, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. 8. Department of Neuroscience, Georgetown University Medical Center, Washington, DC, USA.
Abstract
BACKGROUND: Participants who are enrolled in randomized controlled trials (RCTs) may be more motivated to change their behaviors after being enrolled in a study and that motivation may vary by treatment status. OBJECTIVES: The objectives of this secondary analysis were to investigate if changes in alcohol-related behaviors/characteristics from the baseline to the randomization session differed overall and to assess those differences between non-treatment and treatment seeking individuals with alcohol use disorder (AUD). METHODS: Our sample included participants from eight RCTs conducted at Brown University (N = 281, 34% female). To assess differences across alcohol-related behaviors/characteristics, we investigated changes in craving (obsessive compulsive drinking scale) and alcohol drinking (percent abstinent days, drinks per week (DPW) and percent heavy drinking days (HDD)) overall and between treatment status. RESULTS: Results showed that there were baseline differences, such as increased AUD severity and craving for alcohol in treatment seeking participants (p's < .05) in the overall sample. Next, we showed that craving, DPW and HDD decreased and percent abstinent days increased from baseline to randomization (p's < .05). When controlling for treatment status and sociodemographic characteristics, treatment seeking, compared to non-treatment seeking participants, had a greater reduction in alcohol craving (p < .001) and a greater increase in percentage of drinking days (p < .01). CONCLUSIONS: These findings demonstrated that alcohol-related behaviors and characteristics changed after enrollment. Severity, craving and drinking behaviors also differed between treatment-seeking status, which can potentially impact medication development stages for AUD such as clinical trial eligibility, enrollment and study outcomes.
BACKGROUND: Participants who are enrolled in randomized controlled trials (RCTs) may be more motivated to change their behaviors after being enrolled in a study and that motivation may vary by treatment status. OBJECTIVES: The objectives of this secondary analysis were to investigate if changes in alcohol-related behaviors/characteristics from the baseline to the randomization session differed overall and to assess those differences between non-treatment and treatment seeking individuals with alcohol use disorder (AUD). METHODS: Our sample included participants from eight RCTs conducted at Brown University (N = 281, 34% female). To assess differences across alcohol-related behaviors/characteristics, we investigated changes in craving (obsessive compulsive drinking scale) and alcohol drinking (percent abstinent days, drinks per week (DPW) and percent heavy drinking days (HDD)) overall and between treatment status. RESULTS: Results showed that there were baseline differences, such as increased AUD severity and craving for alcohol in treatment seeking participants (p's < .05) in the overall sample. Next, we showed that craving, DPW and HDD decreased and percent abstinent days increased from baseline to randomization (p's < .05). When controlling for treatment status and sociodemographic characteristics, treatment seeking, compared to non-treatment seeking participants, had a greater reduction in alcohol craving (p < .001) and a greater increase in percentage of drinking days (p < .01). CONCLUSIONS: These findings demonstrated that alcohol-related behaviors and characteristics changed after enrollment. Severity, craving and drinking behaviors also differed between treatment-seeking status, which can potentially impact medication development stages for AUD such as clinical trial eligibility, enrollment and study outcomes.
Authors: Lara A Ray; Spencer Bujarski; Megan M Yardley; Daniel J O Roche; Emily E Hartwell Journal: Am J Drug Alcohol Abuse Date: 2017-04-20 Impact factor: 3.829
Authors: Justine A Grosso; Elizabeth E Epstein; Barbara S McCrady; Ayorkor Gaba; Sharon Cook; Lindsey M Backer-Fulghum; Fiona S Graff Journal: Addict Behav Date: 2013-02-19 Impact factor: 3.913
Authors: Daniel B Rosoff; Toni-Kim Clarke; Mark J Adams; Andrew M McIntosh; George Davey Smith; Jeesun Jung; Falk W Lohoff Journal: Mol Psychiatry Date: 2019-10-25 Impact factor: 15.992