Clinical Trial to Reduce Drinking in Women With HIV

NCT01625091 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 86-2012-NU01AA020797-01
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infection

Keywords

HIV; women; drinking; Naltrexone

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Quit Hazardous Drinking

  The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and \<4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .

  Month 4

Secondary Outcomes (3)

• Number of Binge Drinking Days

  Month 4

• Drinking Problems (SIP-2R Score)

  4 months

• Craving for Alcohol

  4 months

Study Arms (2)

naltrexone

ACTIVE COMPARATOR

The investigators will administer Naltrexone to women with hazardous drinking and assess the study outcomes.

Drug: Naltrexone

placebo pill

PLACEBO COMPARATOR

The investigators will administer an inert placebo that looks similar to Naltrexone, to women with hazardous drinking and assess the study outcomes.

Drug: Placebo

Interventions

Naltrexone DRUG

The study involves taking the drug naltrexone for up to 4 months. This will be given in a single pill each day for 4 months.

naltrexone

Placebo DRUG

Placebo is an inert pill that looks the same as naltrexone. The placebo will be taken once each day for up to 4 months.

placebo pill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead
• Florida International University: collaborator
• University of Miami: collaborator
• Rush University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of Miami

Coral Gables, Florida, 33124, United States

Location

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Robert Cook
• Organization: Unversity of Florida

cookrl@ufl.edu

352-273-5869

Study Officials

• Robert L Cook, MD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 21, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 10, 2018
• Results First Posted: August 2, 2017

Record last verified: 2018-06

Locations

US (2)