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Memory Reconsolidation Blockade for Treating Drug Addiction

Primary Purpose

Substance Dependence

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Propranolol and memory reactivation
Placebo and memory reactivation
Sponsored by
Douglas Mental Health University Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects between 18 and 65 years of age
  • Female subjects must not be of child bearing potential or be non pregnant and be established on an acceptable method of birth control or be one who abstains from sex
  • Diagnosis of substance dependence or substance abuse disorder within a 1-month period prior to screening
  • Currently enrolled in a drug rehabilitation treatment program for marijuana, cocaine, heroin, other opiates, benzodiazepine, alcohol, or amphetamine addictions
  • Individuals who consent to remain abstinent from all drugs of abuse (except nicotine) and from alcohol for 24 hours prior to enrolment and for the duration of the study
  • Individuals treated with the following medications must be on stable doses for at least 1-month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics
  • Individuals taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) must accept to skip their morning dose the day of each study visit
  • Individuals shall not start taking new medications on a regular basis during the study
  • Fluency in French or English

Exclusion Criteria:

  • Systolic blood pressure <100 mm Hg
  • Cardiac rhythm below 55 beats per minute
  • A medical condition that contraindicates the administration of propranolol
  • Previous adverse reaction to, or non-compliance with, beta-blocker
  • Current use of medication that may involve potentially dangerous interactions with propranolol.
  • Women who are pregnant or breast feeding
  • Past or present bipolar disorder or psychosis
  • Individuals with current dependence on any substance besides, cocaine, heroin, other opiates, benzodiazepines, amphetamines, marijuana, or alcohol
  • Subjects judged as being at significant risk of self injurious/suicidal or violent/homicidal behavior
  • Participation in another drug trial within 30 days prior to the screening visit or during the study
  • Any condition that can significantly affect the absorption of the study medication
  • Presence of any clinical condition that might interfere with the interpretation of the efficacy and safety results

Sites / Locations

  • The Heritage Home Drug and Alcohol Rehabilitation Centre
  • Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol and memory reactivation

Placebo and memory reactivation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of days in a drug or alcohol addiction rehabilitation treatment program
Addiction severity
Rates of successfully completing a drug or alcohol rehabilitation program
Rates of planned or unplanned departure and expulsion from a drug or alcohol rehabilitation program
Frequency and intensity of drug or alcohol cravings
Brief psychiatric rating scale
Rates of relapse of drug or alcohol dependence a drug or alcohol rehabilitation program.
Rates of adverse events

Full Information

First Posted
July 3, 2012
Last Updated
May 11, 2017
Sponsor
Douglas Mental Health University Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01634347
Brief Title
Memory Reconsolidation Blockade for Treating Drug Addiction
Official Title
Memory Reconsolidation Blockade for Treating Drug Addiction: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol and memory reactivation
Arm Type
Experimental
Arm Title
Placebo and memory reactivation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol and memory reactivation
Intervention Description
Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation.
Intervention Type
Drug
Intervention Name(s)
Placebo and memory reactivation
Intervention Description
Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation.
Primary Outcome Measure Information:
Title
Substance craving scales
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Addiction severity
Time Frame
Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Title
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
Title
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
Title
Frequency and intensity of drug or alcohol cravings
Time Frame
Once or twice a week for a 3-to-6 week period
Title
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
Title
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
Title
Rates of adverse events
Time Frame
From baseline to 28 days after the last administration of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects between 18 and 65 years of age Female subjects must not be of child bearing potential or be non pregnant and be established on an acceptable method of birth control or be one who abstains from sex Diagnosis of substance dependence or substance abuse disorder within a 1-month period prior to screening Currently enrolled in a drug rehabilitation treatment program for marijuana, cocaine, heroin, other opiates, benzodiazepine, alcohol, or amphetamine addictions Individuals who consent to remain abstinent from all drugs of abuse (except nicotine) and from alcohol for 24 hours prior to enrolment and for the duration of the study Individuals treated with the following medications must be on stable doses for at least 1-month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics Individuals taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) must accept to skip their morning dose the day of each study visit Individuals shall not start taking new medications on a regular basis during the study Fluency in French or English Exclusion Criteria: Systolic blood pressure <100 mm Hg Cardiac rhythm below 55 beats per minute A medical condition that contraindicates the administration of propranolol Previous adverse reaction to, or non-compliance with, beta-blocker Current use of medication that may involve potentially dangerous interactions with propranolol. Women who are pregnant or breast feeding Past or present bipolar disorder or psychosis Individuals with current dependence on any substance besides, cocaine, heroin, other opiates, benzodiazepines, amphetamines, marijuana, or alcohol Subjects judged as being at significant risk of self injurious/suicidal or violent/homicidal behavior Participation in another drug trial within 30 days prior to the screening visit or during the study Any condition that can significantly affect the absorption of the study medication Presence of any clinical condition that might interfere with the interpretation of the efficacy and safety results
Facility Information:
Facility Name
The Heritage Home Drug and Alcohol Rehabilitation Centre
City
Godmanchester
State/Province
Quebec
ZIP/Postal Code
J0S 1H0
Country
Canada
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.sobriety.ca
Description
Related Info

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Memory Reconsolidation Blockade for Treating Drug Addiction

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