Reducing Drug Craving Memories

Cocaine Addiction Clinical Trial

Official title:

Reconsolidation as a Treatment Target for Cocaine Addiction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01319214
• Other study ID #: 10-039-PSY
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2011
• Last updated: May 18, 2011
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: January 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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}

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Drug use	One month after the intervention, participants will be interviewed about their drug and alcohol use	One month after the intervention	No