Beta-blockade Effects on Memory for Cocaine Craving

NCT00830362 | Completed Phase 2 Results DMC

• 4 other identifiers: 18285R21DA025155R21DA025155-01DPMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of propranolol versus placebo on responses to cocaine cues in cocaine dependent individuals.

Conditions

Cocaine Dependence

Keywords

cocaine; cocaine-dependent; propranolol; craving; beta-blockade; cue exposure; drug; addiction; memory; addictive behavior

Outcome Measures

Primary Outcomes (1)

• Single Item Craving Test Session Difference Scores

  Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.

  Both days of cue exposure

Study Arms (2)

Propranolol 40mg

ACTIVE COMPARATOR

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Propranolol DRUG

40 mg administered once

Propranolol 40mg

Placebo DRUG

administered once

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current cocaine dependence (within past month)
• Able to provide informed consent
• Use of birth control by female participants (barrier methods, surgical sterilization, IUD, or abstinence)
• Live within 50-mile radius of research site
• Consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to inpatient admission and follow-up assessment
• Consent to random assignment to propranolol or placebo

You may not qualify if:

• Women who are pregnant, nursing or are of childbearing potential and not practicing/using birth control
• Evidence or history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurological disease
• Significant liver impairment
• History of or current psychotic disorder, current severe major depressive disorder, bipolar affective disorder or a severe anxiety disorder
• Currently taking anti-arrhythmic agents, psychostimulants or other agents known to interfere with heart rate and skin conductance monitoring
• Known or suspected hypersensitivity to propranolol
• Individuals taking medications that could adversely interact with the study medication, including, but not limited to albuterol, insulin, or significant inhibitors of CYP2D6
• Individuals with bronchial asthma or chronic obstructive pulmonary disease

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Lack of a "no retrieval" control group. Lack of determination of plasma propranolol levels following the medicated retrieval session. The sample size was insufficient to assess the more distal effects at 1-week follow-up.

Results Point of Contact

• Title: Dr. Michael Saladin
• Organization: Medical University of South Carolina

saladinm@musc.edu

843-792-5306

Study Officials

• Michael Saladin, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 30, 2012
• Results First Posted: November 30, 2012

Record last verified: 2012-09

Locations

US (1)