Abstract
These analyses of the COMBINE Study examined the effects of naltrexone among non-abstainers. Given that one of the most well-established mechanisms of action of naltrexone involves blunting of alcohol reward, it is hypothesized that naltrexone should be more effective among individuals who drank during treatment. Participants were 952 (78% of the total COMBINE Study sample) treatment-seeking alcohol-dependent men and women who received pharmacotherapy for alcoholism and drank at least once during the 16-week trial. Mixed model analyses revealed that individuals who drank more regularly during the trial seemed to benefit most from naltrexone and the effects of naltrexone on heavy drinking was significant in treatment months 2 through 4 among individuals who reported drinking on 81, 68, and 60% or more of days, respectively. Those drinking frequencies were observed in 11, 15, and 19% of the sample. Similar effects were not observed for drinks per drinking day. These results suggest that a small subgroup of non-abstainers, composed primarily of very regular drinkers, appears to benefit from naltrexone in reducing heavy drinking days. Naltrexone may be effective in the context of controlled-drinking approaches, even among very frequent drinkers.
Highlights
The benefits of naltrexone were not significant at treatment month 1, but became statistically significant at different levels of drinking frequency across treatment months 2, 3, and 4. These findings suggest that a small subgroup of non-abstainers (11–19% of the sample) benefits from naltrexone in reducing heavy drinking days
This study examined the clinical effects of naltrexone among individuals who drank over the course of treatment in the COMBINE Study
It was argued that regular drinking in the presence of active naltrexone treatment would lead to clinical benefits, such as reductions in heavy drinking days and DPDD via naltrexone-induced alteration of the neuropharmacological effects of alcohol
Summary
Naltrexone is an opioid receptor antagonist with empirically supported efficacy for the treatment of alcoholism when used in combination with behavioral treatments (e.g., O’Malley et al, 1992; Volpicelli et al, 1992; Anton et al, 1999, 2006; Monti et al, 2001). After two initial trials suggested that naltrexone resulted in significantly fewer drinking days and lower rates of relapse after 3 months of treatment (O’Malley et al, 1992; Volpicelli et al, 1992), naltrexone was advanced as one of the more promising pharmacological interventions for alcohol dependence (Litten et al, 1996) These initial results have been largely supported by more recent trials of naltrexone that generally demonstrate beneficial effects on heavy drinking rates (Anton et al, 1999; Chick et al, 2000; Monti et al, 2001; Morris et al, 2001). Recent trajectory-based re-analyses of two negative clinical trials suggested that naltrexone may have a clinically meaningful effect in decreasing the risk of consistent heavy drinking and increasing the likelihood of abstinence from alcohol in those studies (Gueorguieva et al, 2007)
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