Reducing Drug Craving Memories

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01319214
Recruitment Status : Unknown
Verified January 2011 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : March 21, 2011
Last Update Posted : May 19, 2011
Information provided by:
McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Drug: Inderal Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reconsolidation as a Treatment Target for Cocaine Addiction
Study Start Date : March 2011
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Drug use [ Time Frame: One month after the intervention ]
    One month after the intervention, participants will be interviewed about their drug and alcohol use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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}

Responsible Party: Marco Leyton, MUHC Identifier: NCT01319214     History of Changes
Other Study ID Numbers: 10-039-PSY
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents