Beta-blockade Effects on Memory for Cocaine Craving

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00830362
First received: January 26, 2009
Last updated: October 31, 2012
Last verified: September 2012
Results First Received: August 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Propranolol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Individuals who met DSM-IV criteria for current cocaine dependence (within the past month) but who were not dependent on any other substance, with the exception of nicotine, served as participants. The primary method of recruitment was media advertisement (radio, local papers) which ran from January of 2009 until July of 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria included severe psychiatric comorbidity (e.g., psychotic disorder, bipolar disorder, severe major depressive disorder with suicidal ideation) or medical illness or use of medications that might interact with propranolol. Individuals with other substance dependence (with exception of nicotine) were also excluded at initial visit.

Reporting Groups
  Description
Propranolol 40mg Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
Placebo Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.

Participant Flow:   Overall Study
    Propranolol 40mg     Placebo  
STARTED     27 [1]   24 [1]
Completed Sessions 1 and 2     26 [2]   24 [3]
COMPLETED     23 [4]   20 [4]
NOT COMPLETED     4     4  
[1] They received Propranolol and completed Test Session (Session 1). One subject left after day 1.
[2] Received propranolol and completed both Test and Retrieval sessions (Session 1 and 2).
[3] Received palcebo and completed both Test and Retrieval sessions (Session 1 and 2).
[4] The enrolled subjects that completed all 3 testing sessions (were not lost to follow-up).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Propranolol 40mg Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
Placebo Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
Total Total of all reporting groups

Baseline Measures
    Propranolol 40mg     Placebo     Total  
Number of Participants  
[units: participants]
  26     24     50  
Age  
[units: years]
Mean ± Standard Deviation
  39.1  ± 1.6     40.8  ± 2.0     39.9  ± 1.3  
Gender  
[units: participants]
     
Female     9     8     17  
Male     17     16     33  



  Outcome Measures

1.  Primary:   Single Item Craving Test Session Difference Scores   [ Time Frame: Both days of cue exposure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Saladin
Organization: Medical University of South Carolina
phone: 843-792-5306
e-mail: saladinm@musc.edu


No publications provided


Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00830362     History of Changes
Other Study ID Numbers: 18285, R21DA025155, R21DA025155-01, DPMC
Study First Received: January 26, 2009
Results First Received: August 24, 2012
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration