Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study

To evaluate the full range of alcohol treatment effectiveness, it is important to assess secondary nondrinking outcome dimensions in addition to primary alcohol consumption outcomes.

We used a large sample (n=1,226) of alcohol-dependent participants entering the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE (Combining Medications and Behavioral Interventions) Study, a multisite clinical trial of pharmacological (naltrexone [ReVia] and acamprosate [Campral]) and behavioral interventions, to examine the effects of specific treatment combinations on nondrinking functional outcomes. We assessed the outcomes at baseline and at the end of 16 weeks of alcohol treatment and again at the 26-week and/or 52-week postrandomization follow-ups.

(1) Drinking and secondary outcomes were significantly related, especially at the follow-up periods. A higher percentage of heavy drinking days, more drinks per drinking day, and lower percentage of days abstinent were associated with lower quality-of-life measures. (2) All nondrinking outcomes showed improvement at the end of 16 weeks of treatment and most maintained improvement over the 26-week and 52-week follow-ups. Only two measures returned to pretreatment levels at 52 weeks: percentage of days paid for work and physical health. Improvements of nondrinking outcomes remained even after adjusting for posttreatment heavy drinking status. (3) Although nondrinking outcomes showed overall improvement, specific pharmacological and behavioral treatment combinations were not differentially effective on specific secondary outcomes.

In the current study, changes that resulted from treatment were multidimensional, and improvements in nondrinking outcomes reflected the overall significant improvement in drinking but they were not differentiated between treatment combination groups. Findings from this study support the importance of including secondary nondrinking outcomes in clinical alcohol-treatment trials.