Clinical trial NCT01227044: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Official title: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Reduction in Heavy Drinking in Patients With HIV
Keywords: Substance Abuse Counseling
Adherence (medication)
Alcohol Abuse
Highly Active Antiretroviral Therapy (HAART)
Naltrexone
Vivitrol
HIV
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-10-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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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Primary outcomes:
measure: HAART Adherence
timeFrame: One year
Secondary outcomes:
measure: Heavy Drinking Days
timeFrame: One year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: VACT Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn E Sullivan (Fiellin), MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav. 2019 Jan;23(1):211-221. doi: 10.1007/s10461-018-2241-z.