Substance DependencePhase 2NCT01634347
Memory Reconsolidation Blockade for Treating Drug Addiction
A Phase 2 study testing Propranolol and memory reactivation in people with Substance Dependence, run by Douglas Mental Health University Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Dependence
- What is being tested?
- Propranolol and memory reactivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2012to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Heritage Home Drug and Alcohol Rehabilitation Centre
Godmanchester, Quebec, J0S 1H0
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Official title: Memory Reconsolidation Blockade for Treating Drug Addiction: a Feasibility Study
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.
Read the 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.
- Conditions
- Substance Dependence
- Being tested
- Propranolol and memory reactivation, Placebo and memory reactivation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol and memory reactivationDrug
Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation.
Placebo and memory reactivationDrug
Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol and memory reactivation | Experimental | Not described Receives: Drug: Propranolol and memory reactivation |
| Placebo and memory reactivation | Placebo comparator | Not described Receives: Drug: Placebo and memory reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 3 or 6
Secondary outcomes (8)
Number of days in a drug or alcohol addiction rehabilitation treatment program
Measured: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Addiction severity
Measured: 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
Measured: 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
Measured: 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
Measured: Once or twice a week for a 3-to-6 week period
Brief psychiatric rating scale
Measured: 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.
Measured: Once or twice a week for a 3-to-6 week period, as well as at 4 months post-baseline
Rates of adverse events
Measured: From baseline to 28 days after the last administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Brunet, Ph.D., Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634347
- Sponsor's protocol ID
- PRPL-004
- Status last verified
- May 2017
- First submitted
- 3 Jul 2012
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Reconsolidation Blockade for Treating Drug Addiction: a Feasibility Study
- ClinicalTrials.gov ID
- NCT01634347
- Acronym / sponsor ID
- PRPL-004
- Conditions
- Substance Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol and memory reactivation | Experimental | Drug: Propranolol and memory reactivation |
| Placebo and memory reactivation | Placebo comparator | Drug: Placebo and memory reactivation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol and memory reactivationPropranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation. | Drug | Propranolol and memory reactivation |
| Placebo and memory reactivationPlacebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation. | Drug | Placebo and memory reactivation |
Primary outcome
Substance craving scales
Time frame: Weeks 3 or 6
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.
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Related InfoLink provided by the sponsor.
Related trials for Substance Dependence
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol and memory reactivation in people with Substance Dependence, run by Douglas Mental Health University Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance craving scales (time frame: Weeks 3 or 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.