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Trial record 4 of 34 for:    " May 16, 2012":" June 15, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION] AND HIV Infections

Clinical Trial to Reduce Drinking in Women With HIV (WHATIF)

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ClinicalTrials.gov Identifier: NCT01625091
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : August 2, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
Florida International University
University of Miami
Rush University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: Naltrexone
Drug: Placebo
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months. The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
Period Title: Intervention
Started 96 98
2 Months 90 93
4 Months 85 87
Completed 85 87
Not Completed 11 11
Reason Not Completed
Death             1             1
Withdrawal by Subject             4             1
Adverse Event             0             2
Lost to Follow-up             4             4
Study termination             2             3
Period Title: Post-intervention
Started 85 87
7 Months 81 85
Completed 81 85
Not Completed 4 2
Reason Not Completed
Death             0             1
Lost to Follow-up             2             0
Study termination             2             1
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months. The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone. Total of all reporting groups
Overall Number of Baseline Participants 96 98 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 98 participants 194 participants
47.7  (8.5) 48.9  (8.9) 48.3  (8.7)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age group Number Analyzed 96 participants 98 participants 194 participants
18-39
16
  16.7%
13
  13.3%
29
  14.9%
40-49
35
  36.5%
32
  32.7%
67
  34.5%
50-59
37
  38.5%
43
  43.9%
80
  41.2%
≥60
8
   8.3%
10
  10.2%
18
   9.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 98 participants 194 participants
Female
96
 100.0%
98
 100.0%
194
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 96 participants 98 participants 194 participants
Hispanic
11
  11.5%
11
  11.2%
22
  11.3%
Not Hispanic, White
3
   3.1%
5
   5.1%
8
   4.1%
Not Hispanic, Black
81
  84.4%
80
  81.6%
161
  83.0%
Not Hispanic, Other
1
   1.0%
2
   2.0%
3
   1.5%
1.Primary Outcome
Title Number of Participants Who Quit Hazardous Drinking
Hide Description The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and <4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .
Time Frame Month 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
Overall Number of Participants Analyzed 85 87
Measure Type: Count of Participants
Unit of Measure: Participants
44
  51.8%
39
  44.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Binge Drinking Days
Hide Description In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).
Time Frame Month 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
Overall Number of Participants Analyzed 85 87
Median (95% Confidence Interval)
Unit of Measure: Days
0
(0 to 1)
1
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Drinking Problems (SIP-2R Score)
Hide Description The Short Inventory of Problems (SIP-2R) seeks to measure the consequences of drinking in participants through questions related to guilt, reliability etc. The SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). The 15 questions from the SIP-2R are summed to create a total range of scores from 0-45.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
Overall Number of Participants Analyzed 85 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.2  (9.9) 6.7  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Craving for Alcohol
Hide Description Self-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months.
The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
Overall Number of Participants Analyzed 85 87
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (3.4) 3.2  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description The participants took the drug naltrexone one single pill (50mg) each day for up to 4 months and then received final assessment at 7-months. The participants took an inert placebo one single pill each day for up to 4-months and then received final assessment at 7-months. Placebo is an inert pill that looks the same as naltrexone.
All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/96 (1.04%)      2/98 (2.04%)    
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/96 (10.42%)      6/98 (6.12%)    
General disorders     
Inpatient hospitalization   10/96 (10.42%)  10 6/98 (6.12%)  6
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/96 (80.21%)      74/98 (75.51%)    
Gastrointestinal disorders     
Nausea   35/96 (36.46%)  29/98 (29.59%) 
Diarrhea   23/96 (23.96%)  27/98 (27.55%) 
Vomiting   22/96 (22.92%)  8/98 (8.16%) 
General disorders     
Fatigue   28/96 (29.17%)  18/98 (18.37%) 
Decreased appetite   21/96 (21.88%)  23/98 (23.47%) 
Sleepiness   24/96 (25.00%)  19/98 (19.39%) 
Dizziness   23/96 (23.96%)  14/98 (14.29%) 
Abdominal pain   20/96 (20.83%)  13/98 (13.27%) 
Insomnia   15/96 (15.63%)  14/98 (14.29%) 
Nervous system disorders     
Headache   28/96 (29.17%)  19/98 (19.39%) 
Psychiatric disorders     
Depression   27/96 (28.13%)  16/98 (16.33%) 
Nervousness/Anxiety   16/96 (16.67%)  18/98 (18.37%) 
Skin and subcutaneous tissue disorders     
Itchiness   15/96 (15.63%)  21/98 (21.43%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Robert Cook
Organization: Unversity of Florida
Phone: 352-273-5869
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01625091     History of Changes
Other Study ID Numbers: 86-2012-N
U01AA020797-01 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2012
First Posted: June 21, 2012
Results First Submitted: July 6, 2017
Results First Posted: August 2, 2017
Last Update Posted: July 10, 2018