Cocaine AddictionNCT01319214
Reducing Drug Craving Memories
A study testing Inderal in people with Cocaine Addiction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- Inderal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2015
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
- Minimum of three days cocaine abstinent on study days;
- Primary use of cocaine is intra-nasal or smoked crack
Who cannot join
- Medical conditions that might be aggravated by participation in the study:
- cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: < 100 mmHg), bradycardia (heart rate < 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: > 160 mmHg; DBP: > 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
- respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
- diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
- Seropositive pregnancy test
- Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
Show all 9Show fewer
- Severe liver disfunction
- Current or recent (< 5 half lives) use of medications that may interact with Inderal (see above)
- Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}
About this study
Official title: Reconsolidation as a Treatment Target for Cocaine Addiction
The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.
- Conditions
- Cocaine Addiction
- Being tested
- Inderal
- Keywords
- cocaine addiction treatment craving
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InderalDrug
Inderal vs. placebo will be administered with or without cocaine cues
| Study group | Role | What they receive |
|---|---|---|
| Inderal, neutral cues | Experimental | Not described Receives: Drug: Inderal |
| Inderal, drug cues | Experimental | Not described Receives: Drug: Inderal |
| Placebo, neutral cues | Experimental | Not described Receives: Drug: Inderal |
| Placebo, drug cues | Experimental | Not described Receives: Drug: Inderal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report drug craving
One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).
Measured: One day and one month post-treatment
Secondary outcomes (1)
Drug use
One month after the intervention, participants will be interviewed about their drug and alcohol use
Measured: One month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319214
- Sponsor's protocol ID
- 10-039-PSY
- Status last verified
- Jan 2011
- First submitted
- 18 Mar 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconsolidation as a Treatment Target for Cocaine Addiction
- ClinicalTrials.gov ID
- NCT01319214
- Acronym / sponsor ID
- 10-039-PSY
- Conditions
- Cocaine Addiction
- Keywords
- cocaine addiction treatment craving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 21 Mar 2011 (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 primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inderal, neutral cues | Experimental | Drug: Inderal |
| Inderal, drug cues | Experimental | Drug: Inderal |
| Placebo, neutral cues | Experimental | Drug: Inderal |
| Placebo, drug cues | Experimental | Drug: Inderal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
- Minimum of three days cocaine abstinent on study days;
- Primary use of cocaine is intra-nasal or smoked crack
Key exclusion criteria (9 listed)
- Medical conditions that might be aggravated by participation in the study:
- Seropositive pregnancy test
- Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
- Severe liver disfunction
- Current or recent (< 5 half lives) use of medications that may interact with Inderal (see above)
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 |
|---|---|---|
| InderalInderal vs. placebo will be administered with or without cocaine cues | Drug | Inderal, drug cues, Inderal, neutral cues, Placebo, drug cues, Placebo, neutral cues |
Primary outcome
Self-report drug craving
Time frame: One day and one month post-treatment
One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).
1 secondary outcome
Drug use
Time frame: One month after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Inderal in people with Cocaine Addiction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Self-report drug craving (time frame: One day and one month post-treatment). 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 19 May 2011.