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Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

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ClinicalTrials.gov Identifier: NCT01764685
Recruitment Status : Terminated (We terminated the study due to problems recruiting alcoholic subjects with HIV.)
First Posted : January 9, 2013
Results First Posted : February 17, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Kranzler, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Heavy Drinking
HIV
Alcohol Dependence
Interventions Drug: Topiramate
Behavioral: Medical Management
Drug: Placebo
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topiramate + Medical Management Placebo Pill + Medical Management
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 0 4
Completed 0 3
Not Completed 0 1
Arm/Group Title Topiramate + Medical Management Placebo Pill + Medical Management Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 0 4 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 4 participants 4 participants
<=18 years 0 0
Between 18 and 65 years 4 4
>=65 years 0 0
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 0 participants 4 participants 4 participants
50
(35 to 63)
50
(35 to 63)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 4 participants 4 participants
Female 0 0
Male 4 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 4 participants 4 participants
4 4
1.Primary Outcome
Title Number of Heavy Drinking Days Per Week by Medication Group
Hide Description Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.
Time Frame 11-week study period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was only collected on 3 of the 4 subjects.
Arm/Group Title Topiramate + Medical Management Placebo Pill + Medical Management
Hide Arm/Group Description:

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 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/wk.

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.

Overall Number of Participants Analyzed 0 3
Measure Type: Number
Unit of Measure: Number of heavy drinking days/week
2
Time Frame Adverse event data was collected over the 11 weeks each subject was enrolled in the study, the total study data was collected of 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topiramate + Medical Management Placebo Pill + Medical Management
Hide Arm/Group Description

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

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.

All-Cause Mortality
Topiramate + Medical Management Placebo Pill + Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Topiramate + Medical Management Placebo Pill + Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Topiramate + Medical Management Placebo Pill + Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      2/4 (50.00%)    
Immune system disorders     
Increase in viral load from start to end of study   0/0  0 2/4 (50.00%)  2
Decrease in viral load from start to end of study   0/0  0 1/4 (25.00%)  1
Renal and urinary disorders     
Hematuria   0/0  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
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.
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
Responsible Party: Henry Kranzler, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01764685     History of Changes
Other Study ID Numbers: 816082
First Submitted: January 4, 2013
First Posted: January 9, 2013
Results First Submitted: August 7, 2015
Results First Posted: February 17, 2016
Last Update Posted: March 15, 2016