Evaluating readiness and treatment seeking effects in a pharmacotherapy trial for alcohol dependence.

BACKGROUND: Decreases in drinking behavior prior to treatment onset often occur in pharmacotherapy trials for alcohol dependence. We propose that these decreases are associated with both trait and state factors operating before initiation of treatment to influence participants' expectation or perception of future treatment outcome. While trait factors typically include personality traits, state factors can include readiness to change and severity of drinking at screening. Understanding the characteristics of changes in drinking early in the process of entering treatment can improve clinical trials and outcomes. Our goal was to evaluate drinking behavior before initiating a randomized, double-blind pharmacotherapy clinical trial for alcohol dependence.
METHODS: We examined the impact of personality factors associated with gregariousness or conformity on the MacAndrew Alcoholism Scale, as well as state factors measured by the Stages-of-Change Scale (based on the University of Rhode Island Change Assessment Scale) and quantity of drinking at screening, on pre-double-blind clinical outcome (i.e., drinking reduction) among 321 male and female alcoholics enrolled in a pharmacotherapy trial.
RESULTS: A significant reduction in alcohol consumption occurred among heavy drinkers between the baseline assessment (10.3 +/- 5.9 drinks per day) and the last week of single-blind placebo administration (5.3 +/- 5.1 drinks per day; p < 0.001). In contrast, the reduction in alcohol consumption by nonheavy drinkers over the same period was not significant (from 3.07 +/- 0.65 to 2.98 +/- 2.6 drinks per day; p > 0.05). Partial correlations indicated that the significant predictors of drinking reductions during this period were: level of drinking (-0.215) and the Stages-of-Change subscales of precontemplation (-0.152), contemplation (0.144), and maintenance (-0.284). Personality factors on the MacAndrew Alcoholism Scale did not predict drinking reductions during this same period.
CONCLUSIONS: Participants with higher motivation levels and greater drinking severity were most likely to reduce their drinking behavior before double-blind treatment. These state factors are important to consider when randomizing participants in trials, and are more important than trait or personality factors in accounting for the initial reduction in drinking in this population during the pretreatment period.

RCT Entities:   Population Interventions Outcomes