A Phase 2 interventional study of Propranolol and memory reactivation and Placebo and memory reactivation in Substance Dependence, sponsored by Douglas Mental Health University Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Douglas Mental Health University Institute · Phase 2, Interventional, and Treatment
The treatment involves administering propranolol, a medication indicated for treating high blood pressure. Propranolol is hypothesized to reduce the strength of drug or alcohol cravings (an integral factor involved in relapse), specifically when memories of substance use are recalled. In this study, propranolol or a placebo will be administered to patients participating in a drug or alcohol rehabilitation facility once a week over three or six weeks. After receiving propranolol or placebo, strong memories associated with substance craving are recalled by asking participants to read aloud a summary of a substance use experience. The investigators hypothesize that participants who receive propranolol will report fewer and less intense drug or alcohol cravings than participants who receive the placebo or treatment-as-usual.
Trial Objectives: To test the feasibility of reconsolidation blockade as an adjunct treatment for reducing drug or alcohol cravings in individuals diagnosed with a substance dependence or substance abuse disorder and participating in a drug rehabilitation program.
Study Design and Duration: This study will be a 3 to 6 week, randomized, double-blind trial involving participants with a DSM-IV-TR diagnosis of substance dependence or abuse. Consented participants meeting enrolment criteria will receive a dose of propranolol (1mg/kg) or placebo ninety minutes before undergoing a brief memory reactivation procedure twice a week for a three-week period (or once a week for a six week period, depending on the participants availability) as an adjunct to their usual drug rehabilitation treatment. Participants will be randomized to one of two treatment arms (i.e. placebo group + treatment as usual, or propranolol group + treatment as usual) and remain in that arm for the duration of the study. Participants from the placebo arm will be offered the opportunity to continue receive open-label propranolol treatment for another 3-6 weeks following the double-blind phase of the study. A four-month follow-up assessment will also be conducted.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 17 is below the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Douglas Mental Health University Institute is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
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Drug: Propranolol and memory reactivation
Drug: Placebo and memory reactivation
Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation.
Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation.
Substance craving scales
The craving scales ask about current craving for substances. Items for the questionnaires represent distinct conceptualizations of substance craving: (1) desire to use; (2) anticipation of positive outcomes from use; (3) anticipation of relief from withdrawal symptoms or relief from negative mood; (4) intention and planning to use; (5) lack of control over use.
Time frame: Weeks 3 or 6
Number of days in a drug or alcohol addiction rehabilitation treatment program
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Addiction severity
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Rates of successfully completing a drug or alcohol rehabilitation program
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Rates of planned or unplanned departure and expulsion from a drug or alcohol rehabilitation program
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Frequency and intensity of drug or alcohol cravings
Time frame: Once or twice a week for a 3-to-6 week period
Brief psychiatric rating scale
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Rates of relapse of drug or alcohol dependence a drug or alcohol rehabilitation program.
Time frame: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Rates of adverse events
Time frame: From baseline to 28 days after the last administration of study medication
The record gives a start of Jan 2012, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Douglas Mental Health University Institute