Reducing Drug Craving Memories
Reconsolidation as a Treatment Target for Cocaine Addiction
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 19, 2011
January 1, 2011
4 years
March 18, 2011
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
One day and one month post-treatment
Secondary Outcomes (1)
Drug use
One month after the intervention
Study Arms (4)
Inderal, neutral cues
EXPERIMENTALInderal, drug cues
EXPERIMENTALPlacebo, neutral cues
EXPERIMENTALPlacebo, drug cues
EXPERIMENTALInterventions
Inderal vs. placebo will be administered with or without cocaine cues
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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}
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 21, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 19, 2011
Record last verified: 2011-01