Reducing Drug Craving Memories

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2011 by McGill University Health Center
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01319214
First received: March 18, 2011
Last updated: May 18, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Cocaine Addiction
Drug: Inderal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reconsolidation as a Treatment Target for Cocaine Addiction

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Self-report drug craving [ Time Frame: One day and one month post-treatment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Drug use [ Time Frame: One month after the intervention ] [ Designated as safety issue: No ]
    One month after the intervention, participants will be interviewed about their drug and alcohol use


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inderal, neutral cues Drug: Inderal
Inderal vs. placebo will be administered with or without cocaine cues
Experimental: Inderal, drug cues Drug: Inderal
Inderal vs. placebo will be administered with or without cocaine cues
Experimental: Placebo, neutral cues Drug: Inderal
Inderal vs. placebo will be administered with or without cocaine cues
Experimental: Placebo, drug cues Drug: Inderal
Inderal vs. placebo will be administered with or without cocaine cues

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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}
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marco Leyton, MUHC
ClinicalTrials.gov Identifier: NCT01319214     History of Changes
Other Study ID Numbers: 10-039-PSY
Study First Received: March 18, 2011
Last Updated: May 18, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McGill University Health Center:
cocaine addiction treatment craving

Additional relevant MeSH terms:
Cocaine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 26, 2014