Trial Outcomes & Findings for Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers (NCT NCT01764685)
NCT ID: NCT01764685
Last Updated: 2016-03-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
11-week study period
Results posted on
2016-03-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
4
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
Baseline characteristics by cohort
| Measure |
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
n=4 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Continuous
|
—
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Gender
Female
|
—
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Gender
Male
|
—
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11-week study periodPopulation: Data was only collected on 3 of the 4 subjects.
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.
Outcome measures
| Measure |
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 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.
|
Placebo Pill + Medical Management
n=3 Participants
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.
|
|---|---|---|
|
Number of Heavy Drinking Days Per Week by Medication Group
|
—
|
2 Number of heavy drinking days/week
|
Adverse Events
Topiramate + Medical Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill + Medical Management
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate + Medical Management
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
|
Placebo Pill + Medical Management
n=4 participants at risk
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.
|
|---|---|---|
|
Immune system disorders
Increase in viral load from start to end of study
|
—
0/0 • 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.
|
50.0%
2/4 • Number of events 2 • 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.
|
|
Renal and urinary disorders
Hematuria
|
—
0/0 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
|
Immune system disorders
Decrease in viral load from start to end of study
|
—
0/0 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
Additional Information
Henry R. Kranzler, M.D.
University of Pennsylvania Perelman School of Medicine
Phone: 215-386-6662
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place