Alcohol Treatment Effects on Secondary Nondrinking Outcomes and Quality of Life: The COMBINE Study

Abstract

ABSTRACT. Objective: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. Method: We used a large sample (n = 1,226) of alcoholdependent 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 specifi c 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. Results: (1) Drinking and secondary outcomes were signifi cantly 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 followups. 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, specifi c pharmacological and behavioral treatment combinations were not differentially effective on specifi c secondary outcomes. Conclusions: In the current study, changes that resulted from treatment were multidimensional, and improvements in nondrinking outcomes refl ected the overall signifi cant 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. (J. Stud. Alcohol Drugs 70: [186][187][188][189][190][191][192][193][194][195][196] 2009)

Quality of life, alcohol detoxification and relapse: Is quality of life a predictor of relapse or only a secondary outcome measure?

“…Thus, maintenance of abstinence led to an improvement of OQOL that involved the patients' environment, social relationships, physical health and, to a lesser extent, psychological health. These findings were consistent with those of previous short-term studies [3-5, 7, 8, 10] and supported the findings of the long-term COMBINE study [17]. In the present study, OQOL among abstinent patients was particularly improved at 6 months after discharge, whereas OQOL was merely maintained at 12 months after discharge.…”

“…Foster et al [50] reported a similar weak baseline correlation between alcohol dependence severity and QOL using a more subjective assessment tool (i.e., LSS). LoCastro et al [17] also found correlations at the 6-and 12-month follow-ups, but these were weaker than those described here. However, despite using the same QOL evaluation tool, the previous study employed a different alcohol use severity assessment.…”

“…Most studies reporting a poorer QOL have used Medical Outcome Study -Short Form healthy survey (MOS-SF)-based tools (e.g., SF-20, SF-36, SF-12), which are expressly designed to assess HQOL [3-5, 7, 8, 10]. Conversely, few studies have adopted the World Health Organization Quality of Life (WHOQOL) tools [17,18], which are currently considered the gold standards for the assessment of OQOL [15]. In view of these different ways of assessing QOL, LoCastro et al [17] included both SF-12 and WHOQOL -Brief version (WHOQOL-BREF) as secondary outcomes in the COMBINE treatment trial.…”

“…Conversely, few studies have adopted the World Health Organization Quality of Life (WHOQOL) tools [17,18], which are currently considered the gold standards for the assessment of OQOL [15]. In view of these different ways of assessing QOL, LoCastro et al [17] included both SF-12 and WHOQOL -Brief version (WHOQOL-BREF) as secondary outcomes in the COMBINE treatment trial. Both tools found patients to have poor QOL at the beginning of the study, and only the psychological and physical domains of the WHOQOL showed improvement between 26 and 52 weeks of follow-up.…”

“…Both tools found patients to have poor QOL at the beginning of the study, and only the psychological and physical domains of the WHOQOL showed improvement between 26 and 52 weeks of follow-up. The study concluded that the WHOQOL tool was more sensitive to variations in drinking patterns than the SF-12 [17]. Moreover, Laudet [15] reported that WHOQOL tools relate more directly to recovery goals than MOS-SF, and encouraged the use of OQOL assessment tools in future prospective studies.…”