Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-08-31

Brief Summary

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This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (\< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.

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Detailed Description

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Conditions

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Reduction in Heavy Drinking in Patients With HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NTX + MM/MC

Naltrexone + Medical Management/Medication Coaching

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.

Placebo + MM/MC

Placebo plus Medical Management/Medication Coaching

Group Type PLACEBO_COMPARATOR

Placebo + Medication Management/Medication Coaching

Intervention Type OTHER

Placebo + Medication Management/Medication Coaching

Interventions

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Naltrexone

NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.

Intervention Type DRUG

Placebo + Medication Management/Medication Coaching

Intervention Type OTHER

Other Intervention Names

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Vivitrol

Eligibility Criteria

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Inclusion Criteria

1. Be HIV-infected.
2. Currently be prescribed HAART medication or be eligible to receive HAART medication.
3. Report less than 95% adherence to their HAART medication.
4. Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
5. Be at least 18 years old.
6. Be able to understand English and provide informed consent.

Exclusion Criteria

1. Be psychotic or severely psychiatrically disabled.
2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
3. Have medical conditions that would preclude completing or be of harm during the course of the study.
4. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
5. Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
6. Be pregnant, nursing or unable to use an effective method of birth control (women).

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No