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A 6-month controlled naltrexone study: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence

Balldin, J; Berglund, Mats LU ; Borg, S; Månsson, Marianne LU ; Bendtsen, P; Franck, J; Gustafsson, L; Halldin, J; Nilsson, L-H and Stolt, G, et al. (2003) In Alcoholism: Clinical and Experimental Research 27(7). p.1142-1149
Abstract
Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed.



Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups—50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching... (More)
Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed.



Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups—50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined.



Results: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects.



Conclusions: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected. (Less)
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Contribution to journal
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published
subject
keywords
craving, cognitive behavioral therapy, naltrexone, alcohol dependence
in
Alcoholism: Clinical and Experimental Research
volume
27
issue
7
pages
1142 - 1149
publisher
Wiley-Blackwell
external identifiers
  • scopus:10744229555
  • pmid:12878920
  • wos:000184354500013
ISSN
0145-6008
DOI
language
English
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yes
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288507ff-b94a-4f34-9af0-4a51fabb5441 (old id 1127058)
date added to LUP
2008-06-02 11:36:43
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2018-05-29 09:22:11
@article{288507ff-b94a-4f34-9af0-4a51fabb5441,
  abstract     = {Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed.<br/><br>
<br/><br>
Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups—50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined.<br/><br>
<br/><br>
Results: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p &lt; 0.010 for aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects.<br/><br>
<br/><br>
Conclusions: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected.},
  author       = {Balldin, J and Berglund, Mats and Borg, S and Månsson, Marianne and Bendtsen, P and Franck, J and Gustafsson, L and Halldin, J and Nilsson, L-H and Stolt, G and Willander, A},
  issn         = {0145-6008},
  keyword      = {craving,cognitive behavioral therapy,naltrexone,alcohol dependence},
  language     = {eng},
  number       = {7},
  pages        = {1142--1149},
  publisher    = {Wiley-Blackwell},
  series       = {Alcoholism: Clinical and Experimental Research},
  title        = {A 6-month controlled naltrexone study: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence},
  url          = {http://dx.doi.org/},
  volume       = {27},
  year         = {2003},
}