HIVPhase 2WHAT-IFNCT01245647
Will Having Alcohol Treatment Improve Functioning?
A Phase 2 study testing Naltrexone, 50mg, once per day for 4 months and Sugar pill, 50mg, once per day for 4 months in people with HIV and Alcoholism, run by University of Florida at 3 sites in United States.
Trial summary
The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Alcoholism
- What is being tested?
- Naltrexone, 50mg, once per day for 4 months and Sugar pill, 50mg, once per day for 4 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hazardous drinking: defined by the NIAAA as either of the following:
- binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA 2005) - OR
- high quantity-frequency (>7 or drinks per week)
- Age 18 or over
- Female
- HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
- Able to understand and comply with planned study procedures.
- Willing and able to provide informed consent.
Who cannot join
- 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 normal); on dialysis for renal failure
- currently taking oral medications for tuberculosis.
- Currently pregnant or positive pregnancy test.
- currently breastfeeding.
- Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).
- currently homeless, unable to provide mailing address, or has plans to move from area within next 7 months.
Show all 12Show fewer
- Unable to communicate in English.
- Research coordinator assessment that participant cannot comprehend the study or consent procedures
- Has current prognosis of less than 1 year to live
- Abnormal vital signs at enrollment visit
- Currently on treatment for Hepatitis C (HCV) infection
- Prisoner status
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Women's Interagency HIV Study
Chicago, Illinois, 60612
University of Florida Health Science Center
Jacksonville, Florida, 32209
Women's Interagency HIV Study
Washington D.C., District of Columbia, 20007
About this study
Official title: Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial
The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.
Read the detailed description
The primary objective of this study is to evaluate the acceptability and effectiveness of a treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings, that involves oral naltrexone. The central hypothesis is that women randomized to the treatment program will have decreased rates of hazardous drinking and improved clinical and behavioral health outcomes that are associated with hazardous drinking. The investigators have formulated this hypotheses based on the existing literature, the preliminary data and the clinical experience. The investigators hypothesize that women randomized to receive an alcohol treatment intervention will be less likely to have hazardous drinking behavior 6-months after enrollment, compared to women who received similar assessments but no formal treatment intervention. The investigators hypothesize that 4-months after enrollment, women randomized to receive an alcohol treatment intervention will have improved adherence to HIV antiretroviral therapy, improved CD4 cell counts, reduced HIV viral load, and reduced risky sexual behavior, compared to women who receive similar assessments but no formal intervention.
The investigators will recruit 90 women from 3 different sites in Florida, Washington DC and Chicago. Of those 90 women 60 will receive naltrexone and 30 will receive placebo. Study participants will take the medication for 4 months but the investigators will follow them for 7 months. At baseline, 2 months, 4 months and 7 months, the investigators will administer study questionnaires and assess their liver enzymes, CD4 count and viral load. The investigators will also follow them up at month 1 and 3 to reinforce the medication intake and to assess for any possible side effects.
New treatment options are available, but their impact on hazardous drinking has not yet been evaluated among HIV-infected women, many of whom are poor, minorities, or who have associated mental health or substance abuse problems. Delivery of therapeutic interventions must be improved in order to reduce hazardous drinking in women with HIV/AIDS. The proposed research is significant because the therapy will be offered within HIV clinic settings and will potentially improve the health of a population that is significantly undertreated. In addition to determining the effectiveness of an alcohol treatment intervention, the investigators will also identify key barriers and facilitators associated with adherence to pharmacologic treatment for alcohol in women with hazardous drinking. The findings will directly impact the type and quality of care for hazardous drinking in this subset of HIV-infected individuals and will inform both primary and secondary prevention efforts
- Conditions
- HIV, Alcoholism
- Being tested
- Naltrexone, 50mg, once per day for 4 months, Sugar pill, 50mg, once per day for 4 months
- Keywords
- women, HIV, alcohol, medication, adherence, acceptability
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone, 50mg, once per day for 4 monthsDrug
Also called Naltrexone
Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.
Sugar pill, 50mg, once per day for 4 monthsOther
Also called Inert sugar pill
Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill, 50mg, once per day for 4 months | Placebo comparator | Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months. Receives: Other: Sugar pill, 50mg, once per day for 4 months |
| Naltrexone, 50mg, once per day for 4 months | Active comparator | Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months. Receives: Drug: Naltrexone, 50mg, once per day for 4 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Per Week
Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.
Measured: Month 4
Secondary outcomes (4)
HIV Medication Adherence (95% or Better)
Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.
Measured: Month 4
Risky Sexual Behaviors
Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.
Measured: 4 months
HIV Viral Load Suppressed
Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)
Measured: 4 months
CD4 Count (Mean)
Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert L Cook, MD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245647
- Sponsor's protocol ID
- AA018934-01-N
- Other IDs
- R01AA018934-01
- Acronym
- WHAT-IF
- Status last verified
- Apr 2018
- First submitted
- 19 Nov 2010
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial
- ClinicalTrials.gov ID
- NCT01245647
- Acronym / sponsor ID
- WHAT-IF / AA018934-01-N
- Conditions
- HIV, Alcoholism
- Keywords
- women, HIV, alcohol, medication, adherence, acceptability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.
Detailed description
The primary objective of this study is to evaluate the acceptability and effectiveness of a treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings, that involves oral naltrexone. The central hypothesis is that women randomized to the treatment program will have decreased rates of hazardous drinking and improved clinical and behavioral health outcomes that are associated with hazardous drinking. The investigators have formulated this hypotheses based on the existing literature, the preliminary data and the clinical experience. The investigators hypothesize that women randomized to receive an alcohol treatment intervention will be less likely to have hazardous drinking behavior 6-months after enrollment, compared to women who received similar assessments but no formal treatment intervention. The investigators hypothesize that 4-months after enrollment, women randomized to receive an alcohol treatment intervention will have improved adherence to HIV antiretroviral therapy, improved CD4 cell counts, reduced HIV viral load, and reduced risky sexual behavior, compared to women who receive similar assessments but no formal intervention.
The investigators will recruit 90 women from 3 different sites in Florida, Washington DC and Chicago. Of those 90 women 60 will receive naltrexone and 30 will receive placebo. Study participants will take the medication for 4 months but the investigators will follow them for 7 months. At baseline, 2 months, 4 months and 7 months, the investigators will administer study questionnaires and assess their liver enzymes, CD4 count and viral load. The investigators will also follow them up at month 1 and 3 to reinforce the medication intake and to assess for any possible side effects.
New treatment options are available, but their impact on hazardous drinking has not yet been evaluated among HIV-infected women, many of whom are poor, minorities, or who have associated mental health or substance abuse problems. Delivery of therapeutic interventions must be improved in order to reduce hazardous drinking in women with HIV/AIDS. The proposed research is significant because the therapy will be offered within HIV clinic settings and will potentially improve the health of a population that is significantly undertreated. In addition to determining the effectiveness of an alcohol treatment intervention, the investigators will also identify key barriers and facilitators associated with adherence to pharmacologic treatment for alcohol in women with hazardous drinking. The findings will directly impact the type and quality of care for hazardous drinking in this subset of HIV-infected individuals and will inform both primary and secondary prevention efforts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill, 50mg, once per day for 4 months | Placebo comparator | Other: Sugar pill, 50mg, once per day for 4 monthsPlacebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months. |
| Naltrexone, 50mg, once per day for 4 months | Active comparator | Drug: Naltrexone, 50mg, once per day for 4 monthsNaltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hazardous drinking: defined by the NIAAA as either of the following:
- Age 18 or over
- Female
- HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.
- Able to understand and comply with planned study procedures.
Key exclusion criteria (12 listed)
- 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 normal); on dialysis for renal failure
- currently taking oral medications for tuberculosis.
- Currently pregnant or positive pregnancy test.
- currently breastfeeding.
- Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone, 50mg, once per day for 4 monthsAlso: NaltrexoneNaltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months. | Drug | Naltrexone, 50mg, once per day for 4 months |
| Sugar pill, 50mg, once per day for 4 monthsAlso: Inert sugar pillPlacebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months. | Other | Sugar Pill, 50mg, once per day for 4 months |
Primary outcome
Number of Drinks Per Week
Time frame: Month 4
Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.
4 secondary outcomes
HIV Medication Adherence (95% or Better)
Time frame: Month 4
Risky Sexual Behaviors
Time frame: 4 months
HIV Viral Load Suppressed
Time frame: 4 months
CD4 Count (Mean)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Cook, MD, MPH principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone, 50mg, once per day for 4 months and Sugar pill, 50mg, once per day for 4 months in people with HIV and Alcoholism, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinks Per Week (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.