|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01625091 |
|
Date of registration:
|
12/06/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Trial to Reduce Drinking in Women With HIV
WHATIF |
|
Scientific title:
|
Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial |
|
Date of first enrolment:
|
December 2012 |
|
Target sample size:
|
194 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01625091 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert L Cook, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Florida |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria: (must meet all of following):
- Hazardous drinking, on average, during the preceding 4 weeks. Defined as binge
drinking (4 or more drinks per occasion at least twice monthly) and/or high total
weekly consumption (>7 drinks per week).
- Age 18 or over
- Female
- HIV infection (documented by medical record blood test result or testing done for this
study)
- Able to understand and comply with study procedures and to provide written consent.
Exclusion criteria: (cannot have any of the following):
- Contraindications to treatment with naltrexone
- Current physiologic opiate dependence
- Current daily prescription opioid medications
- Positive urine drug test for opioids
- Allergic to naltrexone
- Significantly abnormal baseline liver enzymes (AST or ALT >=5 times upper normal),
evidence of acute hepatitis, or receiving hemodialysis for renal failure
- Currently pregnant
- Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone,
acamprosate).
- Currently unable to provide mailing address or reliable contact information, or has
plans to move from area within next 7 months
- Unable to communicate in English or Spanish
- Research coordinator assessment that participant cannot comprehend the study or
consent procedures (e.g. participant appears to be intoxicated, answers questions in a
non-sensible manner)
- Has current prognosis of less than one year to live (e.g. in Hospice, has metastatic
cancer)
- Currently taking antiviral treatment for hepatitis C infection (interferon or
ribavirin)
- Has other unique health condition, not specifically listed, that should exclude the
participant after discussion with Dr. Cook, Dr. Espinoza, and perhaps also the
participant's primary HIV physician (for example an unexpected abnormal laboratory
result turns up on the baseline screening metabolic panel).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Infection
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Naltrexone
|
|
Primary Outcome(s)
|
|
Number of Participants Who Quit Hazardous Drinking
[Time Frame: Month 4]
|
|
Secondary Outcome(s)
|
|
Craving for Alcohol
[Time Frame: 4 months]
|
|
Drinking Problems (SIP-2R Score)
[Time Frame: 4 months]
|
|
Number of Binge Drinking Days
[Time Frame: Month 4]
|
|
Secondary ID(s)
|
|
86-2012-N
|
|
U01AA020797-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|