Memory Reconsolidation Blockade for Treating Drug Addiction

NCT01634347 | Completed Phase 2

• 1 other identifier: PRPL-004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

Propranolol and memory reactivation

EXPERIMENTAL

Drug: Propranolol and memory reactivation

Placebo and memory reactivation

PLACEBO COMPARATOR

Drug: Placebo and memory reactivation

Interventions

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.

Propranolol and memory reactivation

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.

Placebo and memory reactivation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (2)

The Heritage Home Drug and Alcohol Rehabilitation Centre

Godmanchester, Quebec, J0S 1H0, Canada

Location

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

CA (2)