Clinical Trial to Reduce Drinking in Women With HIV
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | December 2012 |
| End Date: | July 2016 |
Pharmacotherapy for Alcohol Consumption in HIV Infected Women: Randomized Trial
The primary objective of this study is to evaluate whether an intervention that involves the
medication naltrexone, will reduce drinking and improve health outcomes in women with HIV
infection and hazardous drinking. Our central hypotheses are that, compared to women who
receive placebo (sugar pill containing no medicine), women who receive naltrexone will have
decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease
progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected
women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and
referrals in Miami, Florida.
Eligible women will receive either a daily pill containing naltrexone (50mg) or an
identical-appearing placebo for four months. All participants will receive encouragement and
feedback related to their drinking regardless of medication assignment. The study
participants will be assessed at two, four and seven months after enrollment. The proposed
work is innovative because pharmacologic treatment for alcohol has not been evaluated in
HIV-infected women. If our hypotheses are confirmed, the study findings would transform the
approach to hazardous drinking within clinics serving HIV-infected women.
medication naltrexone, will reduce drinking and improve health outcomes in women with HIV
infection and hazardous drinking. Our central hypotheses are that, compared to women who
receive placebo (sugar pill containing no medicine), women who receive naltrexone will have
decreased rates of hazardous drinking, improved HIV medication adherence, less rapid disease
progression, and reduced sexual risk behavior. The study design will involve 240 HIV-infected
women with hazardous drinking, who will be recruited from HIV clinics, neighborhoods and
referrals in Miami, Florida.
Eligible women will receive either a daily pill containing naltrexone (50mg) or an
identical-appearing placebo for four months. All participants will receive encouragement and
feedback related to their drinking regardless of medication assignment. The study
participants will be assessed at two, four and seven months after enrollment. The proposed
work is innovative because pharmacologic treatment for alcohol has not been evaluated in
HIV-infected women. If our hypotheses are confirmed, the study findings would transform the
approach to hazardous drinking within clinics serving HIV-infected women.
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 participating in 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 theorize that women who receive an alcohol
treatment intervention will be less likely to have "at risk" 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 who 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 240 women from one site in Miami, Florida. Of those 240 women
120 will receive naltrexone and the others 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 months 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 affect 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.
treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings,
that involves oral naltrexone. The central hypothesis is that women participating in 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 theorize that women who receive an alcohol
treatment intervention will be less likely to have "at risk" 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 who 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 240 women from one site in Miami, Florida. Of those 240 women
120 will receive naltrexone and the others 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 months 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 affect 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.
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).
We found this trial at
2
sites
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1001 Washington Avenue
Miami, Florida 33139
Miami, Florida 33139
Principal Investigator: Maria Miguez, MD, PhD
Phone: 305-355-7056
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