OPIOID ANTAGONISTS IN THE TREATMENT OF ALCOHOL DEPENDENCE: CLINICAL EFFICACY AND PREVENTION OF RELAPSE

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1 Alcohol & Alcoholism, Vol. 31, Suppl. 1, pp , 1996 OPIOID ANTAGONISTS IN THE TREATMENT OF ALCOHOL DEPENDENCE: CLINICAL EFFICACY AND PREVENTION OF RELAPSE STEPHANIE S. O'MALLEY Department of Psychiatry. School of Medicine, Yale University, 1 Long Wharf, Box 18. New Haven, CT 06511, USA (Received 25 September 1995) Abstract Placebo-controlled studies have demonstrated that patients treated with opioid antagonists had fewer drinking days, lower rates of resumed heavy drinking, and reduced alcohol craving, when compared with placebo-treated patients. Patients who received an opioid antagonist were also less likely to drink heavily if they sampled alcohol during treatment. One study also demonstrated that patients who were treated with the opioid antagonist naltrexone had lower serum aspartate aminotransferase and alanine aminotransferase levels than placebo-treated patients. This is consistent with self-reported decreases in alcohol consumption These patients also had less severe alcohol-related problems than placebo-treated patients, as indicated by the Addiction Severity Index. Opioid antagonists might act by reducing the reinforcing effects of alcohol and the incentive to drink. These agents, when combined with comprehensive treatment programmes, are an effective adjunctive treatment for alcohol-dependent patients. INTRODUCTION Opioid antagonists have received considerable attention as pharmacological adjuncts in the treatment of alcohol dependence. Alterations in opioid receptor activity influence alcohol drinking, suggesting that opioid antagonists may be helpful as an adjunct in the treatment of alcohol dependence (Volpicelli, 1987). Data on the opioid antagonists' clinical efficacy and mechanisms of action in reducing alcohol consumption have been evaluated in a series of studies, which will be reviewed in this paper. EFFICACY STUDIES Volpicelli et al. (1990) first studied the effects of administering the opioid antagonist naltrexone to treat alcohol dependence. Their preliminary study included 30 alcohol-dependent men who were outpatients at a Veterans Administration hospital. The 14 patients who received naltrexone and intensive psychosocial treatment were less likely to experience an alcoholic relapse and drank on fewer days than the 16 patients who received placebo. Two subsequent studies confirmed these findings in independent 12-week, double-blind, placebo-controlled clinical trials that used larger samples. In the first study, which included 70 alcohol-dependent male veterans, Volpicelli et al. (1992) found that naltrexone-treated patients had fewer drinking days, lower rates of relapse into heavy drinking and reduced craving for alcohol when compared with placebo-treated patients. Among those patients who sampled alcohol, naltrexone reduced the probability of relapse into heavy drinking. Approximately 95% of the placebo-treated patients who sampled alcohol met the relapse criteria [reported drinking s=5 days in 1 week or 5=5 drinks per drinking occasion or coming to the treatment appointment with a blood alcohol concentration (BAC) >100mg/dl], whereas only 50% of the naltrexone-treated patients experienced a relapse (Volpicelli et al., 1992). In the second study, O'Malley et al. (1992) studied 104 alcohol-dependent men and women who were randomized to one of four treatment groups. Patients received either naltrexone or placebo in combination with one of two forms of psychotherapy: coping skills/relapse prevention therapy or supportive therapy. Compared with placebo-treated patients, naltrexone-treated patients consumed one-third of the number of drinks during treatment and drank on half as many days. Naltrexone-treated patients were more likely to Medical Council on Alcoholism

2 78 S. S OMALLEY a <n a. m <D E i la i I L NsBrexono/Coping SMU Therapy Nsttroxone/Supportrve Therapy Hicsbo/Copmg SkBs Therapy Placebo/Supportive Therapy i \ Days Fig. 1. Effects of naltrexone on rate of relapse of alcoholics. Adapted with permission from O'Malley el al. (1992). For details, see the text. remain abstinent and less likely to resume heavy drinking than placebo-treated patients. As shown in Fig. 1, there was a significant difference in the time to first relapse in the treatment groups (F = 0.007). Median time to relapse was 35 and 25 days respectively for the placebo/supportive and for the placebo/coping skills conditions. Only 34% of the naltrexone/supportive group and 43% of the naltrexone/coping skills group had relapsed by the end of the 12-week trial. Consistent with self-reports of decreased alcohol consumption, naltrexone-treated patients had lower serum aspartate aminotransferase and serum alanine aminotransferase levels at the end of the study. These patients also had less severe alcohol-related problems than placebo-treated patients, as indicated by Addiction Severity Index measures of alcohol use, drug use and employment problems (O'Malley et al., 1992). The consistency of the findings from these two studies indicates that naltrexone is effective in treating alcohol dependence. The fact that different patient populations were studied and different psychosocial interventions were used in conjunction with the medication strengthens the generalizability of these findings. These two investigations used three different types of concurrent psychosocial interventions. Patients in the trial by Volpicelli et al. (1992) participated in an intensive day treatment programme for 1 month and attended appointments twice weekly for the remaining 2 months of the study. Patients in the study by our group received either coping skills/relapse prevention therapy or supportive therapy on a weekly basis. The coping skills/relapse prevention therapy was a structured cognitive behavioural intervention designed to teach the patient new strategies for coping without the use of alcohol. The supportive therapy provided support and encouragement for the patient's own strategies to remain abstinent and prohibited the use of coping skills techniques. Patients in the trial by Volpicelli et al. (1992) were exclusively male and predominantly African American and required detoxification. In contrast, those in the O'Malley et al. (1992) study included women and its patients were predominantly white and reported fewer years of drinking. Two subsequent studies on the use of opioid antagonists have also been completed (Mason et al., 1994; Bohn et al., 1994). In a small pilot trial, Mason et al. (1994) examined the efficacy of nalmefene, a new experimental opioid antagonist derived from naltrexone. Twenty-one patients were randomized to receive either 10 mg of nalmefene, 40 mg of nalmefene, or placebo for a period of 12 weeks. Patients attended research appointments, but concurrent therapy was not provided. Compared with the other treatment groups, the group that received 40 mg of nalmefene had a significantly lower alcoholic relapse rate (Ps=0.05) and a greater increase in the number of days per week in which they abstained from drinking alcohol (P=s0.09). Nalmefenetreated patients who sampled alcohol during treatment consumed significantly fewer drinks per day when compared with placebo-treated patients (P «0.04). The serum alanine aminotransferase levels of nalmefene-treated patients were also decreased. These results, which are consistent with the results from trials of naltrexone, provide additional evidence that opioid antagonists are effective adjunctive agents that can reduce alcohol consumption, maintain sobriety, and prevent alcoholic relapse among many alcohol-dependent patients (Mason et al., 1994). One finding has been consistently reported from the clinical trials of opioid antagonists: patients who receive these medications are less likely than placebo-treated patients to drink heavily if they sample alcohol during treatment. Although the goal for alcohol-dependent patients who receive

3 OPIOID ANTAGONISTS IN ALCOHOLISM TREATMENT r 60 _ D_ O 30 O Pretreatment Treatment Treatment Period PostUeatment Fig. 2. Changes in serum >*-glutaniyl transpeptidase (GGTP) levels in 14 non-dependent heavy drinkers before and after 6 weeks of treatment with brief counselling and either 25 or 50 mg of naltrexone. Adapted with permission from Bohn el al. (1994). For other details, see the text. Values are means ± SD. P < 0.03 (two-way ANOVA) for overall effects; *P =s 0.05 (Scheffi) versus pretreatment level; t/ > >0.20 (Scheffe) versus treatment level. naltrexone is to remain abstinent, this consistent finding suggests that naltrexone could also be used to augment interventions aimed at reducing alcohol consumption among heavy drinkers who are not alcohol-dependent. Excessive alcohol consumption is far more prevalent than alcohol dependence. It is also associated with alcoholrelated disease and health care utilization (Hilton, 1987; Siegel etai., 1991; Bohn etai., 1994). Bohn et al. (1994) have conducted an initial evaluation of the safety and potential efficacy of naltrexone as an adjunct to brief counselling in reducing alcohol consumption among heavy drinkers. In this study, 14 subjects who met the criteria for heavy drinking (consuming s*60 drinks/month and &5 drinks per occasion at least weekly) were randomized to receive brief counselling and either 25 or 50 mg of naltrexone daily for 6 weeks. An initial 30 min counselling session was used to identify goals for reduction or cessation of drinking, teaching of self-monitoring techniques, and identification of alternatives to drinking. Subsequent 10 min follow-up sessions were used to monitor progress and to suggest additional alternatives to heavy drinking. The results of this study indicate that naltrexone was well tolerated and was associated with improved hepatic enzyme levels (Fig. 2). Naltrexone at both dose levels reduced the frequency and intensity of drinking during treatment and during a 1 month follow-up period (Bohn et al., 1994). Since this study was not placebo-controlled, the relative contributions of the counselling and naltrexone to these findings cannot be established. A placebo-controlled trial to test the efficacy of naltrexone in non-alcoholdependent heavy drinkers is being conducted currently by the group of Bohn. MECHANISMS OF ACTION In the two clinical trials in which naltrexone was used in the treatment of alcohol dependence (O'Malley et al., 1992; Volpicelli et al., 1992), it was observed that subjects receiving naltrexone were less likely to relapse into heavy drinking than subjects who received placebo. This effect was most pronounced among those subjects who 'sampled' alcohol. In addition, naltrexone was associated with reduced craving for alcohol (Volpicelli et al., 1992) and increased abstinence rates (O'Malley et al., 1992). One hypothesis for these findings is that naltrexone may attenuate some of the reinforcing effects of alcohol that would otherwise lead to further drinking following an initial drink or from conditioned neuroendocrine responses to alcohol-related cues (Volpicelli et al., 1992; O'Malley, 1995). The reinforcing effects of alcohol that motivate alcoholic patients to continue drinking, however, are unlikely to be related to pleasurable effects. Robinson and Berridge (1993) argue that for those individuals who are addicted to alcohol (or other substances) the pleasurable effects become less important over time, and sensitization of 'wanting' or 'craving' the substance becomes the salient motivation for drinking. Consistent with this hypothesis, studies of substance-induced relapse have shown that, instead of satisfying drug craving, craving remains high or is increased by drug administration (Engle and Williams, 1972; Ludwig et al., 1974; Meyer and Kranzler, 1988; Ehrman etai, 1992; Robinson and Berridge, 1993). If naltrexone blocks craving induced by alcohol-related stimuli or alcohol consumption, this may explain the observed reduction in relapse to heavy drinking noted in previous clinical trials. To understand how naltrexone minimizes the likelihood of resumed heavy drinking, several

4 80 S. S. OMALLEY investigators have attempted to examine how naltrexone modifies the experience of intoxication. Volpicelli et al. (1995) and O'Malley et al. (1996) asked the patients who participated in their original 1992 clinical trials to fill out a questionnaire following the first reported sampling of alcohol. In the Volpicelli study, 36 patients used a 3-point scale to report on the subjective effects of drinking. Patients who received naltrexone reported feeling less 'high' and less intoxicated than usual, compared with patients who received placebo. Naltrexone-treated patients were also less likely to report heavy drinking during an initial episode of drinking than placebo-treated patients (Volpicelli et al., 1995). In the O'Malley study, naltrexone-treated patients were also less likely to resume heavy drinking when they initially sampled alcohol. When asked to rate the subjective effects of alcohol during this initial episode of drinking, naltrexone-treated patients reported lower levels of intoxication and craving for alcohol. In response to an open-ended question, 'Why did you stop this drinking episode?', the majority of naltrexonetreated patients gave reasons that were consistent with reductions in craving and in the urge to drink (e.g. 'wanted to', 'didn't want another drink'). In contrast, placebo-treated patients were more likely to give responses that reflected the negative consequences of drinking (e.g. 'I was intoxicated', 'I felt guilty') (O'Malley et al., 1994). These studies suggest that naltrexone may reduce the reinforcing effects of alcohol and the incentive to drink. Thus, it may be easier for naltrexone-treated patients to stop drinking if they sample alcohol, and this may also explain, in part, their lower relapse rates. The lower levels of intoxication reported by naltrexone-treated patients in the clinical trials, however, are difficult to interpret, because the naltrexone-treated patients also consumed fewer drinks. A more direct assessment of the effects of naltrexone on ethanol intoxication has been conducted (Swift et al., 1994). In a double-blind, cross-over study, 20 non-alcoholic volunteers received 50 mg of naltrexone on one day and a matching placebo on another. On both days, subjects consumed a moderate dose of alcohol (0.65 ml/kg for women and 0.75 ml/kg for men) ~1 h after receiving the medication. Mood, stimulatory and sedative effects of alcohol, cognitive performance and blood alcohol levels were measured. Of interest, alcohol's pharmacokinetic activity and impairment of cognitive performance were similar for the naltrexone and placebo treatment sessions. However, measures of the stimulatory and sedative effects of alcohol revealed differences. Subjects reported lower levels of stimulation and higher levels of sedation from alcohol on the day they received naltrexone, compared with the day they received placebo. Furthermore, 75% of the subjects reported liking alcohol more when they received placebo than when they received naltrexone. Based on these findings, Swift et al. (1994) concluded that naltrexone may reduce alcohol consumption by decreasing the positive reinforcing effects of alcohol and selectively intensifying some of the discriminative features of alcohol intoxication, such as sedation. An additional observation in the study by Swift et al. (1994) was the trend for greater nausea with naltrexone than placebo, but this was not statistically significant (P>0.10). The investigators reported that four subjects vomited on the day they received naltrexone and ethanol but did not vomit on the day they received placebo and ethanol. One possible explanation for these findings is that naltrexone, like disulfiram, interacts with ethanol to produce nausea, and thereby makes alcohol aversive. An alternative explanation is that these subjects were likely to experience nausea from naltrexone independent of interactions with ethanol. In the Swift etal. (1994) study, peak plasma levels of naltrexone would have coincided with the time of ethanol administration, which occurred min after naltrexone was administered (Vereby et al., 1976; Meyer et al., 1984). Nausea is a common sideeffect of naltrexone that often occurs within 1-2 h of taking the medication. In a large multi-site safety study (Croop et al., 1995), nausea was the most frequently reported new-onset adverse event, and it occurred in 10% of the alcoholdependent subjects. These studies provide some initial insights into the way in which naltrexone may modify the effects of alcohol and suggest hypotheses about how the medication reduces the risk of relapse following an initial slip. However, these studies are not conclusive. Future research is needed to better understand the mechanism underlying naltrexone's efficacy.

5 OPIOID ANTAGONISTS IN ALCOHOLISM TREATMENT 81 CONCLUSIONS The evidence to date indicates that naltrexone, when offered as part of a comprehensive treatment programme, is an effective adjunctive treatment for alcohol-dependent patients who wish to maintain abstinence and reduce the likelihood of experiencing a relapse. The finding that naltrexone-treated patients are less likely to resume heavy drinking after sampling alcohol suggests that naltrexone may modify aspects of alcohol intoxication that reinforce or induce additional drinking. Ultimately, the effectiveness of opioid antagonists will depend on a range of factors, such as the characteristics of the patient population, the intensity of the concurrent psychosocial treatments provided and the optimal matching of patients and treatments. REFERENCES Bohn, M. J., Kranzler, H. R., Beazoglou, D. and Staehler, B. A. (1994) Naltrexone and brief counseling to reduce heavy drinking: results of a small clinical trial. American Journal on Addictions 3, Croop, R. S., Labriola, D F., Wroblewski, J. M. and Nibbelink, D. W. (1995) A multicenter safety study of naltrexone as adjunctive pharmacotherapy for individuals with alcoholism. Presented at the annual meeting of the American Psychiatric Association, May 20-25, 1995, Miami, Florida Ehrman, R., Ternes. J., O'Brien, C. P. and McLellan, A. T. (1992) Conditioned tolerance in human opiate addicts. Psychopharmacology 108, Engle.K. B. and Williams, T. K. (1972) Effect of an ounce of vodka on alcoholics' desire for alcohol. Quarterly Journal of Studies of Alcohol 33, Hilton, M. E. (1987) Drinking patterns and drinking problems in 1984: results from a general population survey. Alcoholism: Clinical and Experimental Research 11, Ludwig, A. M., Wikler, A. and Stark, L. H. (1974) The first drink: psychobiological aspects of craving. Archiues of General Psychiatry 30, Mason, B. J., Ritvo, E C, Morgan, R. O., Salvato, F. R., Goldberg, G., Welch, B. and Mantero-Atienza, E (1994) A double-blind, placebo-controlled pilot study to evaluate the efficacy and safety of oral nalmefene HC1 for alcohol dependence. Alcoholism: Clinical and Experimental Research 18, Meyer, M. C, Straughn, A. B., Lo, M.-W., Senary, W. L. and Whitney, C. C. (1984) Bioequivalence, doseproportionality, and pharmacokinetics of naltrexone after oral administration. Journal of Clinical Psychiatry 45, Meyer. R. E. and Kranzler. H R. (1988) Alcoholism: clinical implications of recent research. Journal of Clinical Psychiatry 49 (Suppl. 9), O'Malley, S. S. (1995) Strategies to maximize the efficacy of naltrexone for alcohol dependence. In Integrating Behavioral Therapies with Medications in the Treatment of Drug Dependence, Onken, L. S., Blaine, J. D. and Boren. J. J. eds, pp National Institute of Drug Abuse Monograph 150, NIH Publication No ; National Institutes of Health, Bethesda. O'Malley, S S., Jaffe, A. J, Chang, G., Schottenfeld, R. S., Meyer, R. E. and Rounsaville, B. (1992) Naltrexone and coping skills therapy for alcohol dependence: a controlled study. Archiues of General Psychiatry 49, O'Malley, S. S., Jaffe, A. J., Rode, S. and Rounsaville, B. J. (19%) Experience of a 'slip' among alcoholics treated with naltrexone or placebo. American Journal of Psychiatry 153, Robinson, T. E. and Bemdge, K. C. (1993) The neural basis of drug craving: an incentive-sensitization theory of addiction Brain Research Reviews 18, Siegel, P. Z., Brackbill, R M, Frazier, E. L., Mariolis, P, Sanderson, L. M. and Waller, M. N. (1991) Behavioral risk factor surveillance, Morbidity and Mortality Weekly Report 40, (No. SS-4), Swift, R. M., Whelihan, W., Kuznetsov, O., Buongiorno, G. and Hsuing, H. (1994) Naltrexone-induced alterations in human ethanol intoxication. American Journal of Psychiatry Verebey, K., Volavka, J., Mul6, S. J. and Resnick, R. B. (1976) Naltrexone' disposition, metabolism, and effects after acute and chronic dosing. Clinical Pharmacology and Therapeutics 20, Volpicelli, J. R. (1987) Uncontrollable events and alcohol drinking. British Journal of Addiction 82, Volpicelli, J. R., O'Brien, C. P., Alterman, A. I. and Hayashida, M. (1990) Naltrexone and the treatment of alcohol dependence: initial observations. In Opioids, Bulimia, and Alcohol Abuse and Alcoholism, Reid, L. D. ed., pp Springer-Verlag, New York. Volpicelli, J. R., Alterman, A. I., Hayashida, M. and O'Brien, C. P. (1992) Naltrexone in the treatment of alcohol dependence. Archives of General Psychiatry 49, Volpicelli, J. R., Watson, N. T. King, A. C. and Sherman, C. E. (1995) Effect of naltrexone on alcohol 'high' in alcoholics. American Journal of Psychiatry 152,

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