Memory Reconsolidation Blockade for Treating Drug Addiction

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.

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