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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol and memory reactivation | Experimental |
| |
| Placebo and memory reactivation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol and memory reactivation | Drug | Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 3 or 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days in a drug or alcohol addiction rehabilitation treatment program | Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline | |
| Addiction severity | Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heritage Home Drug and Alcohol Rehabilitation Centre | Godmanchester | Quebec | J0S 1H0 | Canada | ||
| Douglas Mental Health University Institute |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo and memory reactivation | Drug | Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation. |
|
| Rates of successfully completing a drug or alcohol rehabilitation program | 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 | 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 | Once or twice a week for a 3-to-6 week period |
| Brief psychiatric rating scale | 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. | Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline |
| Rates of adverse events | From baseline to 28 days after the last administration of study medication |
| Montreal |
| Quebec |
| H4H 1R3 |
| Canada |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |