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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions: Alcohol Abuse
Alcohol Dependence
Interventions: Drug: ondansetron
Drug: placebo ondansetron
Drug: Ondansetron

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
357 persons signed informed consent; 205 were randomized. 137 exclusions were mainly due to insufficient alcohol use (as determined by self-report or biomarker), abnormal QT interval, or significant mental health symptoms that precluded assessment completion. An additional 13 participants withdrew, were discontinued by the investigators or died.

Reporting Groups
  Description
Placebo Ondansetron - Sugar Pill

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

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

Low Dose Ondansetron (0.2 mg Bid) ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Moderate Dose Ondansetron (0.8 mg Bid) Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration

Participant Flow:   Overall Study
    Placebo Ondansetron - Sugar Pill   Low Dose Ondansetron (0.2 mg Bid)   Moderate Dose Ondansetron (0.8 mg Bid)
STARTED   67   69   69 
COMPLETED   57   58   64 
NOT COMPLETED   10   11   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Ondansetron - Sugar Pill

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

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

Low Dose Ondansetron (0.2 mg Bid) ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Moderate Dose Ondansetron (0.8 mg Bid) Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Total Total of all reporting groups

Baseline Measures
   Placebo Ondansetron - Sugar Pill   Low Dose Ondansetron (0.2 mg Bid)   Moderate Dose Ondansetron (0.8 mg Bid)   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   69   69   205 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.7  (8.7)   48.7  (8.2)   47.8  (9.5)   48.7  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      21  31.3%      23  33.3%      27  39.1%      71  34.6% 
Male      46  68.7%      46  66.7%      42  60.9%      134  65.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Black   65   66   64   195 
Other   2   3   5   10 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   67   69   69   205 
Number of drinks per drinking day 
[Units: Standard alcohol drink]
Mean (Standard Deviation)
 9.1  (5.5)   10.5  (7.7)   10.0  (8.7)   9.9  (7.3) 
Number of days abstinent from alcohol/week 
[Units: Days/week]
Mean (Standard Deviation)
 2.9  (1.9)   3.0  (2.1)   3.3  (1.9)   3.1  (2.0) 


  Outcome Measures

1.  Primary:   Number of Alcoholic Containing Drinks Per Drinking Day   [ Time Frame: 16 weeks ]

2.  Primary:   Number of Days/Week Abstinent From Alcohol   [ Time Frame: 16 weeks ]

3.  Secondary:   Medication Safety   [ Time Frame: 16 weeks ]

4.  Secondary:   Number of Subjects Who Discontinue Due to Side Effects   [ Time Frame: 16 weeks ]

5.  Secondary:   Alcohol-related Problems   [ Time Frame: 16 weeks ]

6.  Secondary:   HIV Medication Adherence   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Drinking data are based on patient self-report.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary E McCaul
Organization: JohnHopkinsU
phone: 410-955-9526
e-mail: mmccaul1@jhmi.edu


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01254877     History of Changes
Other Study ID Numbers: NA_00032774
R01AA018896 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: January 29, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018