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Alcohol dependence assessment and treatment |
Four clinical interview questions, the CAGE questions (1), have proved useful in helping to make a diagnosis of alcoholism. Whilst a positive response to the CAGE interview is not diagnostic of alcoholism, a positive response should, however, alert the interviewer to the high likelihood of the presence of alcoholism. Gamma-glutamyl transpeptidase detected only one third of those consuming more than 16 drinks a day or independently diagnosed as alcoholic. In contrast the CAGE interviews identified nine out of ten alcoholics and detected 93% of excessive drinkers.
Since its introduction the CAGE has become recognised as one of the most efficient and effective screening devices. One positive response calls for further inquiry. Two or three affirmative answers should create a high index of suspicion. Four positive responses are seen as pathognomonic for alcoholism.
The CAGE is not only seen as easy to administer, sustainable in GP practice and reliable in distinguishing alcoholics, but also as less intimidating than some of the other instruments. Mayfield (2) chose to identify alcoholism by the existence of two or more affirmative responses, and many clinical and research studies have followed his lead (3,4,5,6).
It has been suggested that the GP could paraphrase the four questions to suit the occasion without significantly altering the validity, provided that the GP specifically focuses on Cutting down, Annoyance by criticism, Guilty feelings, and Eye-openers that maintains the acronym CAGE. However, the exact wording the researchers used is provided as follows:
- Have you ever felt you ought to cut down on your drinking?
- Have people annoyed you by criticising your drinking?
- Have you ever felt bad or guilty about your drinking?
- Have you ever had a drink first thing in the morning to steady your nerves or get rid of a hangover (eye-opener)?
Seventy male alcohol-dependent patients participated in a 12 week, double blind, placebo controlled trial of naltrexone hydrochloride (50mg/d) as an adjunct to treatment following alcohol detoxification (7). Subjects taking naltrexone reported significantly less alcohol craving and days in which any alcohol was consumed. For purposes of the research, clinically significant drinking or alcohol relapse was defined as:
1. Reporting drinking five or more days within one week;
2. Reporting five or more drinks per drinking session;
3. Coming to the treatment appointment with a blood alcohol concentration above 100 mg/dL.
Demographically, the two samples did not differ. The reasons for the premature termination show that 11 (79%) of the 14 noncompleters in the placebo treated group droppped out because of alcohol relapse. In contrast, only five (45%) of 11 noncompleters in the naltrexone treated group dropped out because of relapse.
A comparison of mean number of reported drinking days a week shows that subjects receiving placebo drank an average of 8.3% of the study days (0.57 days per week), whereas naltrexone treated subjects drank an average of 1.6% of the study days (0.11 days per week). However, naltrexone had its most important effect in decreasing subsequent drinking once drinking occurred. Among subjects who sampled alcohol, the placebo treated group averaged drinking on 14.0% of the study days (0.98 drinking days per week), whereas the naltrexone treated group averaged drinking on 3.6% of the study days (0.25 drinking days per week).
The percentage of subjects who relapsed in the naltrexone treated group was significantly less than that of the placebo treated group. Nineteen (54%) of the 35 placebo treated subjects relapsed, whereas only eight (23%) of the 35 subjects from the naltrexone treated group relapsed. This difference is statistically significant. Of the 20 subjects who sampled alcohol in the placebo treated group, 19 (95%) met the criteria for relapse, while only eight (50%) of the 16 known drinkers in the naltrexone treated group relapsed. This difference is statistically significant.
Naltrexone treatment had no effect on psychopathological condition as assessed by the clinician related brief psychiatric rating scale.
An ideal pharmacological adjunct to alcoholism treatment should have the following three properties:
1. It should decrease the craving for alcohol so that the motivation to drink decreases;
2. It should block the reinforcing properties of alcohol so that, if drinking occurs, there is neither enhancement of pleasant feelings or reduction of distressing feelings;
3. The medication should be free of adverse physical and emotional consequences.
The researchers believe that from the results presented naltrexone appears to be an effective adjunct to the treatment of alcohol dependence. In this sample, naltrexone decreased craving, mean drinking days, and relapse rates. It seemed to be particularly effective in decreasing drinking in subjects who had at least one slip; that is, naltrexone helped stop the resumption of binge drinking typically seen in placebo treated subjects.
In addition, naltrexone was well tolerated, with few side effects (nausea in two subjects and increased arthritic in one subject), and no deleterious effects on mood and psychopathological condition. In the placebo treated group, over 95% of the subjects who sampled alcohol met the relapse criteria and drank clinically significant amounts of alcohol. This is consistent with common clinical observations that alcohol dependent patients who sample alcohol often 'lose control' over their drinking. In comparison, only 50% of the naltrexone treated patients who drank any alcohol met the relapse criteria.
This study had several limitations that must be considered before concluding that naltrexone is an effective treatment for alcohol dependence. First, treatment outcome was assessed only for three months. While naltrexone may help decrease initial relapse rates, the data do not speak to the long term effectiveness of naltrexone. However, as there did not appear to be any loss of effectiveness of naltexone during the trial, it encourages the researchers to believe that up regulation may not be a significant problem. Second, it must be remembered that all subjects in the study were involved in concurrent group therapy for alcohol dependence. Thus, an important qualifying condition for this study is the use of naltrexone in a supportive and therapeutic environment. Third, the dependent variables that led to statistically significant group effects depended on the subjects' self reports. The use of collateral data from the subjects' significant others would have strengthened the validity of the findings.
In another study (8), 97 alcohol dependent patients were treated for 12 weeks in a double blind, placebo controlled study evaluating naltrexone and two manual guided psychotherapies in the treatment of alcohol dependence. Subjects were randomised into one of four treatment conditions: naltrexone and coping skills treatment; naltrexone and supportive therapy; placebo and coping skills treatment; and placebo and supportive therapy. This 2x2 factorial research design permits the evaluation of independent and additive effects of pharmacotherapy (naltrexone or placebo) and psychotherapy (coping skills or supportive therapy).
The coping skills/relapse prevention therapy was based on the cognitive-behavioural model of substance abuse (9) and is designed to foster acquisition of coping skills. The therapy is manual guided (10,11) and uses didactic presentations, cognitive and behavioural rehearsal within sessions, and homework exercises. Patients learn to identify and handle situations that place them at high risk for the resumption of drinking.
The main components of the program are:
1. Self-monitoring and functional analysis of drinking behaviour and urges to drink;
2. Training and rehearsal of coping behaviours, such as anger management, social skills, and stress management;
3. Cognitive and behavioural coping strategies for handling problems, urges, and cravings;
4. Instruction in problem solving and decision making skills; and
5. Development of abstinence-oriented leisure activities.
Patients are informed about the abstinence violation effect (7) in which a 'slip' or initial lapse to drinking is followed by negative self-evaluations that exacerbate the relapse process. Patients are encouraged to develop strategies to prevent a lapse from turning into a relapse, including monitoring and changing their thoughts and feelings following a slip and using new behaviours such as leaving the situation or calling a friend. Therapist adherence to treatment guidelines was monitored through clinical supervision and review of audiotapes of therapy sessions.
Subjects were accessed prior to treatment (baseline), weekly during treatment, at termination from treatment, and at a six month follow up.
Naltrexone treated patients experienced nausea (32.7%), weight loss (24.5%) and dizziness (34.7%); these were typically experienced immediately after the initial dose and led to five patients discontinuing the treatment. Medication compliance was typically high. Because of concerns about possible hepatotoxic reactions associated with naltrexone use, the researchers (8) examined end-point aspartate aminotransferase and alanine aminotranferase levels. Compared with placebo treated subjects, naltrexone treated subjects had significantly lower aspartate aminotransferase levels and a similar trend was noted for alanine aminotransferase.
Substantially less than half the subjects in the naltrexone/supportive (34%) and the naltrexone/coping skills (43%) groups had relapsed by the end of the 12 week trial. Subjects taking naltrexone and receiving either supportive or coping skills therapy had a relative risk of relapse that was about two thirds less than the risk for subjects taking placebo who received coping skills therapy. In two-way comparisons subjects who were maintained on a regimen of naltrexone and received coping skills therapy had one fourth the risk of relapse compared with subjects taking placebo who received coping skills treatment. A significant medication by treatment interaction, however, was revealed for the 39 completers who drank, with subjects in the naltrexone/ coping skills condition drinking less per occasion than patients in the placebo/coping skills condition. Ratings of craving over the past week were made on a 20-point analogue scale. Subjects in the naltrexone/coping skills condition reported lower levels of craving than subjects in the placebo/coping skills therapy condition.
Naltrexone was found to be clearly superior to placebo on a number of measures related to alcohol consumption and alcohol related problems. If drinking was initiated, however, subjects receiving naltrexone who had been trained in coping skills/relapse prevention were less likely to experience a relapse to heavy drinking than subjects receiving naltrexone who were not taught coping skills and than subjects receiving placebo. These findings suggest that although naltrexone may enhance abstinence rates, subjects taking naltrexone who receive coping skills/relapse prevention therapy as implemented in this study were more likely to experiment with drinking than subjects who received supportive therapy. However, naltrexone was associated with less frequent alcohol consumption, reduced rates of relapse, and lower aspartate aminotransferase levels compared with placebo.
The naltrexone treated patients may have been more compliant because of the benefit they received from taking the medication. Improvements in alcohol consumption and better functioning in employment and psychological wellbeing may have reinforced compliance. These findings suggest that medication effects may be both direct and indirect, the later operating through a feedback loop of reciprocal reinforcement.
In a study (12) designed to collect safety data in a setting that reflected the expected clinical use of naltrexone, no new safety concerns were identified. This was a 12-week, non-randomised, open label usage study conducted in 40 alcoholism treatment centres throughout the United States. At study entry, patients must have been abstinent from alcohol for 1 to 6 weeks and enrolled in a psychosocial treatment program for alcoholism.
Patients often underrepresented in controlled clinical trials, including women and patients with comorbid medical and psychiatric illness, were eligible. Patients with polysubstance abuse or infection with the human immunodeficiency virus were not excluded.
Of 1076 patients screened for this study, 865 patients were enrolled; of these, 295 patients were assigned to the reference group and 570 were assigned to the naltrexone group. The most common new onset adverse clinical events in the naltrexone group were nausea (9.8%) and headache (6.6%) Naltrexone was discontinued in 15% of patients because of adverse events, most commonly nausea. The results of liver function tests in the naltrexone group were similar to those in the reference group. No deaths occurred during the study.
References
1.Ewing, JA, 1984. Detecting Alcoholism. The CAGE Questionnaire. Journal of the American Medical Association, 252(14): 1905-7.
2. Mayfield, DG, McLeod, G & Hall, P, 1974. The CAGE Questionnaire: Validation of a new alcoholism screening instrument. American Journal of Psychiatry, 131: 1121-1123.
3.Screening Tests for Alcoholism, editorial 1980. Lancet, 2: 1117-8.
4. Beresford, T, Low, D, Adduci, R, 1982.Alcohol Assessment on an Orthopeadic Surgery Service. Journal of Bone & Joint Surgery. 64A: 730-3.
5. Bernadt, M, Mumford, J, Taylor, C, 1982. Comparison of Questionnaire and Laboratory Tests in the Detection of Excessive Drinking & Alcoholism. Lancet, 1: 325-8.
6. Detecting & Assessing Alcoholism, editorial 1982. Alcohol Clinical Update, 1:2-5.
7. Volpicelli, JR, Alterman, AI, Hayashida, M & O'Brien, CP, 1992. Naltrexone in the Treatment of Alcohol Dependence. Archives of General Psychiatry, 49: 876-80.
8. O'Malley, SS, Jaffe, AJ, Chang, G, Schottenfeld, RS, Meyer, RE & Rounsaville, B, 1992. Naltrexone & Coping Skills Therapy for Alcohol Dependence. Archives of General Psychiatry, 49: 881-7.
9. Marlatt, GA & Gordon, JR, eds.,1985. Relapse Prevention. New York, NY:Guildford Press.
10. Jaffe, AJ, Korner, P, Witte, G & Brown, J, 1989. Relapse Prevention for the Treatment of Problem Drinking: A Manual for Therapists & Patients. New Haven, Conn:Yale University School of Medicine; Farmington, Conn: University of Connecticut Health Center.
11. Carroll, K & Schottenfield, R, 1988. A Therapist's Manual for Relapse Prevention in the Treatment of Alcoholism. New Haven, Conn: Yale University School of Medicine.
12. Croop, RS, Faulkner, EB, & Labriola, DF, 1997. The Safety Profile of Naltrexone in the Treatment of Alcoholism. Archives of General Psychiatry, 54: 1130-5.
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