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

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ClinicalTrials.gov Identifier: NCT01254877
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Johns Hopkins University

December 6, 2010
December 7, 2010
January 29, 2018
April 17, 2018
April 17, 2018
December 2010
January 2017   (Final data collection date for primary outcome measure)
  • Number of Alcoholic Containing Drinks Per Drinking Day [ Time Frame: 16 weeks ]
    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
  • Number of Days/Week Abstinent From Alcohol [ Time Frame: 16 weeks ]
    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.
  • number of drinks per drinking day [ Time Frame: 16 weeks ]
    The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain the primary dependent measure. Alcohol use is assessed biweekly and quantified over the 16-week medication period
  • Total number of days abstinent from alcohol [ Time Frame: 16 weeks ]
    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. Total number of days abstinent will be calculated as the number of abstinent days divided by the number of days elapsed (adjusted for days in confinement (e.g., hospitalization; jail)).
Complete list of historical versions of study NCT01254877 on ClinicalTrials.gov Archive Site
  • Medication Safety [ Time Frame: 16 weeks ]
    Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events.
  • Number of Subjects Who Discontinue Due to Side Effects [ Time Frame: 16 weeks ]
    The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.
  • Alcohol-related Problems [ Time Frame: 16 weeks ]
    Alcohol-related problems were measured using the Short Inventory of Problems - revised (SIP-R), a self-report inventory of adverse consequences associated with alcohol and drug use. The SIP instructs participants to indicate how often each of 15 consequences has occurred during the past three months ("never," "once or a few times," "once or twice a week," "daily or almost daily"; scored 0-3). Item responses are summed to produce a total score and five subscale scores. Total scores range from 0 - 45.
  • HIV Medication Adherence [ Time Frame: 16 weeks ]
    The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses.
  • Medication Safety [ Time Frame: 16 weeks ]
    Medication side-effects and adverse events will be measured using the SAFTEE.
  • Number of Subjects Who Discontinue Due to Side Effects [ Time Frame: 16 weeks ]
    The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.
  • Alcohol-related Problems [ Time Frame: 16 weeks ]
    The investigators will measure alcohol-related problems using the SIP-2R, a widely used and well validated instrument.
  • HIV medication persistence [ Time Frame: 16 weeks ]
    The investigators will obtain patient self reports of HIV medication persistance as well as a visual analog scale of % persistence.
  • HIV risk behaviors [ Time Frame: 16 weeks ]
    Risk behaviors will be measured based on self report
  • Quality of life [ Time Frame: 16 weeks ]
    Quality of life will be measured based on subject self report.
Not Provided
Not Provided
 
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women
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.

Hazardous drinking is particularly harmful in HIV-infected persons. It impairs the immune system, accelerates HIV disease progression, slows initiation of antiretroviral therapy (ART) and decreases adherence. Thus, the development of effective alcohol treatments for this clinical population is particularly important. The investigators are proposing to investigate the effectiveness of ondansetron pharmacotherapy for the treatment of hazardous alcohol use and alcohol abuse/dependence among HIV-infected patients. Ondansetron, a 5-HT3 antagonist, will be studied for several reasons: 1) evidence of effectiveness in persons who want to cut-down or reduce their drinking and who are not abstinent at medication initiation; 2) moderate-to-strong effects among early onset problem drinkers, a characteristic that is over represented in our clinic patients; 3) a very mild side-effect profile, making it an ideal pharmacotherapy candidate in patients who are often receiving multiple other medications with significant side-effects; and 4) its primary indication is for treatment of nausea, a common side-effect of antiretroviral (ARV) medications.

The proposed study is a placebo-controlled, randomized clinical trial of ondansetron for the treatment of hazardous drinking and alcohol use disorders among HIV-infected patients recruited from the Baltimore/Washington area. Participants will be genotyped for a functional polymorphism of the serotonin transporter gene. They will be randomized to one of three treatment groups: placebo, low dose ondansetron (0.2 mg bid) and moderate dose ondansetron (0.8 mg bid). All subjects will undergo 16 weeks of pharmacotherapy in combination with medication management, and will be followed for 3 and 6 months after medication has ended.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Alcohol Abuse
  • Alcohol Dependence
  • Drug: ondansetron
    ondansetron 0.2 mg bid, oral preparation, 16 weeks
  • Drug: placebo ondansetron
    Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.
  • Drug: Ondansetron
    Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
  • Placebo Comparator: Placebo Ondansetron - sugar pill
    Placebo is an oral preparation made to appear and taste like the active drug preparation.
    Intervention: Drug: placebo ondansetron
  • Experimental: low dose ondansetron (0.2 mg bid)
    Intervention: Drug: ondansetron
  • Experimental: moderate dose ondansetron (0.8 mg bid)
    Intervention: Drug: Ondansetron
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
300
January 2017
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01254877
NA_00032774
R01AA018896 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Johns Hopkins University
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Mary E McCaul, Ph.D. Johns Hopkins University
Johns Hopkins University
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP