Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

NCT01254877 | Completed Phase 2 Results DMC

• 2 other identifiers: NA_00032774R01AA018896
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist ondansetron. The investigators predict that participants who are treated with active doses of ondansetron will reduce their drinking more and show better HIV treatment participation and progress compared to participants who are treated with placebo. This study will provide important new safety and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy in HIV-infected persons.

Conditions

Alcohol Abuse; Alcohol Dependence

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• Number of Alcoholic Containing Drinks Per Drinking Day

  The Time-line Follow-back (TLFB; Sobell, Sobell, Leo \& Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period

  16 weeks

• Number of Days/Week Abstinent From Alcohol

  The Time-line Follow-back (Sobell, Sobell, Leo \& Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7.

  16 weeks

Secondary Outcomes (4)

• Medication Safety

  16 weeks

• Number of Subjects Who Discontinue Due to Side Effects

  16 weeks

• Alcohol-related Problems

  16 weeks

• HIV Medication Adherence

  16 weeks

Study Arms (3)

Placebo Ondansetron - sugar pill

PLACEBO COMPARATOR

Placebo is an oral preparation made to appear and taste like the active drug preparation.

Drug: placebo ondansetron

low dose ondansetron (0.2 mg bid)

EXPERIMENTAL

Drug: ondansetron

moderate dose ondansetron (0.8 mg bid)

EXPERIMENTAL

Drug: Ondansetron

Interventions

Ondansetron DRUG

ondansetron 0.2 mg bid, oral preparation, 16 weeks

low dose ondansetron (0.2 mg bid)

placebo ondansetron DRUG

Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.

Placebo Ondansetron - sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be at least 18 years old and HIV-infected
• All subjects will be actively drinking at hazardous levels (1) AUDIT score =\> 4 for women or =\>8 for men, or 2) =\> 2 binge drinking episodes/month, or 3) \>7 drinks/week for women or \>14 drinks/week for men)

You may not qualify if:

• Liver Function Tests (LFTs) \> 5 X normal
• Magnesium or potassium \> 3 X normal
• Qtc =\> .460 and or a family history of long QT syndrome (LQT)
• Inability to read and comprehend English
• Actively psychotic or other severe mental health symptoms that would prevent appropriate participation
• Current enrollment in alcoholism treatment program
• Pregnancy; Ondansetron is currently a category B drug. While animal data have not identified any harmful effects to mother or fetus, there have not been adequate human controlled trials to recommend routine use in this population

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Johnson BA, Roache JD, Javors MA, DiClemente CC, Cloninger CR, Prihoda TJ, Bordnick PS, Ait-Daoud N, Hensler J. Ondansetron for reduction of drinking among biologically predisposed alcoholic patients: A randomized controlled trial. JAMA. 2000 Aug 23-30;284(8):963-71. doi: 10.1001/jama.284.8.963.

  PMID: 10944641 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Drinking data are based on patient self-report.

Results Point of Contact

• Title: Mary E McCaul
• Organization: JohnHopkinsU

mmccaul1@jhmi.edu

410-955-9526

Study Officials

• Mary E McCaul, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

US (1)