Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

This study has been terminated.
(We terminated the study due to problems recruiting alcoholic subjects with HIV.)
Sponsor:
Information provided by (Responsible Party):
Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01764685
First received: January 4, 2013
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: August 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Heavy Drinking
HIV
Alcohol Dependence
Interventions: Drug: Topiramate
Behavioral: Medical Management
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topiramate + Medical Management

Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit

Topiramate: Max therapeutic dose of 150 mg/day

Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.

Placebo Pill + Medical Management

Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit

Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.


Participant Flow:   Overall Study
    Topiramate + Medical Management     Placebo Pill + Medical Management  
STARTED     0     4  
COMPLETED     0     3  
NOT COMPLETED     0     1  



  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
Topiramate + Medical Management

Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit

Topiramate: Max therapeutic dose of 150mg/day

Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.

Placebo Pill + Medical Management

Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit

Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.

Total Total of all reporting groups

Baseline Measures
    Topiramate + Medical Management     Placebo Pill + Medical Management     Total  
Number of Participants  
[units: participants]
  0     4     4  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         4     4  
>=65 years         0     0  
Age  
[units: years]
Mean (Full Range)
        50   (35 to 63)     50   (35 to 63)  
Gender  
[units: participants]
     
Female         0     0  
Male         4     4  
Region of Enrollment  
[units: participants]
     
United States         4     4  



  Outcome Measures

1.  Primary:   Number of Heavy Drinking Days Per Week by Medication Group   [ Time Frame: 11-week study period ]


  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
We closed our enrollment before meeting recruitment goals, due to difficulties with recruitment. We didn't analyze our data, due to a sample size of 4, that were all randomized to placebo group and only 3 of the 4 completed the study procedures.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Henry R. Kranzler, M.D.
Organization: University of Pennsylvania Perelman School of Medicine
phone: 215-386-6662
e-mail: kranzler@mail.med.upenn.edu



Responsible Party: Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01764685     History of Changes
Other Study ID Numbers: 816082
Study First Received: January 4, 2013
Results First Received: August 7, 2015
Last Updated: February 16, 2016
Health Authority: United States: Institutional Review Board