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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625091
First Posted: June 21, 2012
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: July 6, 2017  
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

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Naltrexone 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.
Placebo 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.

Participant Flow for 2 periods

Period 1:   Intervention
    Naltrexone   Placebo
STARTED   96   98 
2 Months   90   93 
4 Months   85   87 
COMPLETED   85   87 
NOT COMPLETED   11   11 
Death                1                1 
Withdrawal by Subject                4                1 
Adverse Event                0                2 
Lost to Follow-up                4                4 
Study termination                2                3 

Period 2:   Post-intervention
    Naltrexone   Placebo
STARTED   85   87 
7 Months   81   85 
COMPLETED   81   85 
NOT COMPLETED   4   2 
Death                0                1 
Lost to Follow-up                2                0 
Study termination                2                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
Naltrexone 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.
Placebo 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 Total of all reporting groups

Baseline Measures
   Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 96   98   194 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (8.5)   48.9  (8.9)   48.3  (8.7) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age group       
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 
[Units: Participants]
Count of Participants
     
Female      96 100.0%      98 100.0%      194 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
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% 


  Outcome Measures
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1.  Primary:   Quit Hazardous Drinking   [ Time Frame: Month 4 ]

2.  Secondary:   Number of Binge Drinking Days   [ Time Frame: Month 4 ]

3.  Secondary:   SIP-2R Score   [ Time Frame: 4 months ]

4.  Secondary:   Craving for Alcohol   [ Time Frame: 4 months ]


  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
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  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. Robert Cook
Organization: Unversity of Florida
phone: 352-273-5869
e-mail: cookrl@ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01625091     History of Changes
Other Study ID Numbers: 86-2012
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: August 2, 2017