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Clinical Trial
. 2003 Nov 18:3:16.
doi: 10.1186/1471-244X-3-16.

Baclofen for maintenance treatment of opioid dependence: a randomized double-blind placebo-controlled clinical trial [ISRCTN32121581]

Seyed Mohammad Assadi  1 , Reza Radgoodarzi, Seyed Ali Ahmadi-Abhari
Affiliations
Clinical Trial

Baclofen for maintenance treatment of opioid dependence: a randomized double-blind placebo-controlled clinical trial [ISRCTN32121581]

Seyed Mohammad Assadi et al. BMC Psychiatry. .

Abstract

Background: Results of preclinical studies suggest that the GABA(B) receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence.

Methods: A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day) or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. Secondary outcome measures included opioids and alcohol use according to urinalysis and self-report ratings, intensity of opioid craving assessed with a visual analogue scale, opioid withdrawal symptoms as measured by the Short Opiate Withdrawal Scale and depression scores on the Hamilton inventory.

Results: Treatment retention was significantly higher in the baclofen group. Baclofen also showed a significant superiority over placebo in terms of opiate withdrawal syndrome and depressive symptoms. Non-significant, but generally favorable responses were seen in the baclofen group with other outcome measures including intensity of opioid craving and self-reported opioid and alcohol use. However, no significant difference was seen in the rates of opioid-positive urine tests. Additionally, the drug side effects of the two groups were not significantly different.

Conclusion: The results support further study of baclofen in the maintenance treatment of opioid dependence.

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Figures

Figure 1
Figure 1
The primary portion of brain reward circuitry appears to be a subset of dopaminergic projections originating in the ventral tegmental area (VTA) and terminating in the nucleus accumbens (NA). VTA is modulated by GABAergic inputs. GABAB receptors inhibit VTA cell bodies, i.e., when stimulated, hyperpolarize the membrane potential and decrease firing rates of VTA neurons.
Figure 2
Figure 2
Trial profile
Figure 3
Figure 3
Percentage of patients in each group who remained in treatment.
Figure 4
Figure 4
Self-reported days of opioid use per week during the 12 weeks of maintenance treatment with baclofen and placebo.
Figure 5
Figure 5
Mean Short Opiate Withdrawal Scale (SOWS) scores during the 12 weeks of maintenance treatment with baclofen and placebo.
Figure 6
Figure 6
Mean Hamilton Depression Rating Scale (HAM-D) scores during the 12 weeks of maintenance treatment with baclofen and placebo.
See this image and copyright information in PMC

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References

    1. Cousins MS, Roberts DC, de Wit H. GABAB receptor agonists for the treatment of drug addiction: a review of recent findings. Drug Alcohol Depend. 2002;65:209–220. doi: 10.1016/S0376-8716(01)00163-6. - DOI - PubMed
    1. Shoaib M, Swanner LS, Beyer CE, Goldberg SR, Schindler CW. The GABAB agonist baclofen modifies cocaine self-administration in rats. Behav Pharmacol. 1998;9:195–206. - PubMed
    1. Campbell UC, Lac ST, Carroll ME. Effects of baclofen on maintenance and reinstatement of intravenous cocaine self-administration in rats. Psychopharmacology (Berl) 1999;143:209–214. doi: 10.1007/s002130050937. - DOI - PubMed
    1. Roberts DC, Andrews MM, Vickers GJ. Baclofen attenuates the reinforcing effects of cocaine in rats. Neuropsychopharmacology. 1996;15:417–423. doi: 10.1016/0893-133X(96)00002-4. - DOI - PubMed
    1. Brebner K, Phelan R, Roberts DC. Effect of baclofen on cocaine self-administration in rats reinforced under fixed-ratio 1 and progressive-ratio schedules. Psychopharmacology (Berl) 2000;148:314–321. doi: 10.1007/s002130050056. - DOI - PubMed

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