Will Having Alcohol Treatment Improve Functioning? (WHAT-IF)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01245647
First received: November 19, 2010
Last updated: January 10, 2014
Last verified: August 2013
Results First Received: August 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
Alcoholism
Interventions: Drug: Naltrexone, 50mg, once per day for 4 months
Other: Sugar pill, 50mg, once per day for 4 months

  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
We recruited participants from 3 sites in 3 cities: Washington, D.C., Chicago, and Jacksonville from December 2010 to February 2012. The last participant completed her 7-Month follow-up at October 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Sugar Pill, 50mg, Once a Day for 4 Months. Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
Naltrexone, 50mg, Once a Day for 4 Months Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.

Participant Flow:   Overall Study
    Sugar Pill, 50mg, Once a Day for 4 Months.     Naltrexone, 50mg, Once a Day for 4 Months  
STARTED     7     12  
COMPLETED     7     8  
NOT COMPLETED     0     4  



  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
Sugar Pill, 50mg, Once a Day for 4 Months Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
Naltrexone, 50mg, Once a Day for 4 Months Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Total Total of all reporting groups

Baseline Measures
    Sugar Pill, 50mg, Once a Day for 4 Months     Naltrexone, 50mg, Once a Day for 4 Months     Total  
Number of Participants  
[units: participants]
  7     12     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     12     19  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  50.2  ± 9.3     48.7  ± 6.6     49.3  ± 7.5  
Gender  
[units: participants]
     
Female     7     12     19  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     7     12     19  



  Outcome Measures
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1.  Primary:   Number of Drinks Per Week   [ Time Frame: Month 4 ]

2.  Secondary:   HIV Medication Adherence (95% or Better)   [ Time Frame: Month 4 ]

3.  Secondary:   Risky Sexual Behaviors   [ Time Frame: 4 months ]

4.  Secondary:   HIV Viral Load Suppressed   [ Time Frame: 4 months ]

5.  Secondary:   CD4 Count (Mean)   [ 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
Sample size was very small, and 3 participants did not return for any follow-up visits; 15 completed through the Month 4 assessment, and 12 completed through Month 7. Therefore, our ability to draw conclusions based on this sample is limited.


  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: Dr. Bob Cook
Organization: University of Florida
phone: 352-273-5869
e-mail: cookrl@ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01245647     History of Changes
Other Study ID Numbers: AA018934-01, R01AA018934-01
Study First Received: November 19, 2010
Results First Received: August 27, 2013
Last Updated: January 10, 2014
Health Authority: United States: Federal Government