Reducing Drug Craving Memories

NCT ID: NCT01319214

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Cocaine Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inderal, neutral cues

Group Type: EXPERIMENTAL

Inderal

Intervention Type: DRUG

Inderal vs. placebo will be administered with or without cocaine cues

Inderal, drug cues

Group Type: EXPERIMENTAL

Inderal

Intervention Type: DRUG

Inderal vs. placebo will be administered with or without cocaine cues

Placebo, neutral cues

Group Type: EXPERIMENTAL

Inderal

Intervention Type: DRUG

Inderal vs. placebo will be administered with or without cocaine cues

Placebo, drug cues

Group Type: EXPERIMENTAL

Inderal

Intervention Type: DRUG

Inderal vs. placebo will be administered with or without cocaine cues

Interventions

Inderal

Inderal vs. placebo will be administered with or without cocaine cues

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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}

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

MUHC

Other Identifiers

10-039-PSY

Identifier Type: -

Identifier Source: org_study_id