Opioid Reduction
Study register · detail RCT · Opioid Reduction · 2015

The effects of dronabinol during detoxification and the initiation of treatment with extended release naltrexone.

Mixed GRADE Moderate 96 citations
Samplen = 60 Pat.
Duration8 weeks
ControlPlacebo
EndpointSOWS
Blindingdoppelblind
DesignRCT
Cannabinoidthc
Max. dose30.0 mg
Routeoral
Key finding

Dronabinol significantly reduced the severity of opioid withdrawal during inpatient detoxification (p=0.006), but had no effect on the induction rate for XR-naltrexone or treatment compliance.

Summary

n=60 opioid-dependent patients, dronabinol 30mg/d vs. placebo during detoxification and extended-release naltrexone induction. Dronabinol reduced withdrawal severity (SOWS, p=0,006), but no effect on XR-naltrexone induction rate (66% vs. 55%) or treatment completion (35% vs. 35%). Post-hoc: 32% with regular cannabis use had lower insomnia/anxiety scores and higher completion rate.

P
PopulationOpioid-dependent adults during inpatient detoxification and naltrexone induction, n=60
I
InterventionDronabinol 30 mg/day orally, during inpatient detoxification and 5 weeks outpatient (plus XR-naltrexone injection)
C
ControlPlacebo (double-blind, plus XR-naltrexone injection)
O
OutcomeOpioid withdrawal severity (SOWS) during inpatient phase significantly lower under dronabinol vs. placebo (p=0,006); no significant difference in XR-naltrexone induction rate (66% vs. 55%) or treatment completion (35% vs. 35%)
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Mixed
Citations / year
Authors
Bisaga A, Sullivan MA, Glass A, Mishlen K, Pavlicova M, Haney M, Raby WN, Levin FR, Carpenter KM, Mariani JJ
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Abstract
Background: Evidence suggests that the cannabinoid system is involved in the maintenance of opioid dependence. We examined whether dronabinol, a cannabinoid receptor type 1 partial agonist, reduces opioid withdrawal and increases retention in treatment with extended release naltrexone (XR-naltrexone). Methods: Opioid dependent participants were randomized to receive dronabinol 30mg/d (n=40) or placebo (n=20), under double-blind conditions, while they underwent inpatient detoxification and naltrexone induction. Before discharge all participants received an injection of XR-naltrexone, with an additional dose given four weeks later. Dronabinol or placebo was given while inpatient and for 5 weeks afterwards. The primary outcomes were the severity of opioid withdrawal, measured with the Subjective Opioid Withdrawal Scale, and retention in treatment at the end of the inpatient phase and at the end of the 8-week trial. Results: The severity of opioid withdrawal during inpatient phase was lower in the dronabinol group relative to placebo group (p=0.006). Rates of successful induction onto XR-naltrexone (dronabinol 66%, placebo 55%) and completion of treatment (dronabinol 35%, placebo 35%) were not significantly different. Post hoc analysis showed that the 32% of participants who smoked Cannabis regularly during the outpatient phase had significantly lower ratings of insomnia and anxiety and were more likely to complete the 8-week trial. Conclusion: Dronabinol reduced the severity of opiate withdrawal during acute detoxification but had no effect on rates of XR-naltrexone treatment induction and retention. Participants who elected to smoke Cannabis during the trial were more likely to complete treatment regardless of treatment group assignment.

The impediment to action advances action. — Marcus Aurelius