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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
Enrollment 357
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Period Title: Overall Study
Started 67 69 69
Completed 57 58 64
Not Completed 10 11 5
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid) Total
Hide Arm/Group Description

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration Total of all reporting groups
Overall Number of Baseline Participants 67 69 69 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 69 participants 205 participants
49.7  (8.7) 48.7  (8.2) 47.8  (9.5) 48.7  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 69 participants 205 participants
Black
65
  97.0%
66
  95.7%
64
  92.8%
195
  95.1%
Other
2
   3.0%
3
   4.3%
5
   7.2%
10
   4.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 67 participants 69 participants 69 participants 205 participants
67
 100.0%
69
 100.0%
69
 100.0%
205
 100.0%
Number of drinks per drinking day  
Mean (Standard Deviation)
Unit of measure:  Standard alcohol drink
Number Analyzed 67 participants 69 participants 69 participants 205 participants
9.1  (5.5) 10.5  (7.7) 10.0  (8.7) 9.9  (7.3)
Number of days abstinent from alcohol/week  
Mean (Standard Deviation)
Unit of measure:  Days/week
Number Analyzed 67 participants 69 participants 69 participants 205 participants
2.9  (1.9) 3.0  (2.1) 3.3  (1.9) 3.1  (2.0)
1.Primary Outcome
Title Number of Alcoholic Containing Drinks Per Drinking Day
Hide Description 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
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: Standard alcohol drinks per drinking day
5.9  (3.8) 6.1  (4.3) 5.9  (3.9)
2.Primary Outcome
Title Number of Days/Week Abstinent From Alcohol
Hide Description 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.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: days/week abstinent from alcohol
4.7  (2.2) 4.9  (2.0) 4.8  (2.2)
3.Secondary Outcome
Title Medication Safety
Hide Description 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.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: number of events
11.4  (11.1) 12.4  (13.4) 11.0  (12.3)
4.Secondary Outcome
Title Number of Subjects Who Discontinue Due to Side Effects
Hide Description The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Alcohol-related Problems
Hide Description 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.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.6  (7.3) 7.5  (7.9) 8.3  (15.7)
6.Secondary Outcome
Title HIV Medication Adherence
Hide Description 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.
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description:

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks
Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
Overall Number of Participants Analyzed 67 69 69
Mean (Standard Deviation)
Unit of Measure: percentage of prescribed doses
92.4  (31.6) 87.6  (37.6) 85.4  (31.7)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Hide Arm/Group Description

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.

ondansetron: ondansetron 0.2 mg bid, oral preparation, 16 weeks Ondansetron: Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
All-Cause Mortality
Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/67 (1.49%)      0/67 (0.00%)      1/69 (1.45%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/67 (23.88%)      20/69 (28.99%)      5/69 (7.25%)    
Cardiac disorders       
cardiovascular event   4/67 (5.97%)  4 1/69 (1.45%)  1 0/69 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain   4/67 (5.97%)  4 2/69 (2.90%)  2 0/69 (0.00%)  0
General disorders       
Other   2/67 (2.99%)  2 5/69 (7.25%)  5 1/69 (1.45%)  1
Psychiatric disorders       
Acute Alcohol Intoxication  [1]  2/67 (2.99%)  2 6/69 (8.70%)  6 0/69 (0.00%)  0
Psychiatric disorder   2/67 (2.99%)  2 2/69 (2.90%)  2 4/69 (5.80%)  4
Respiratory, thoracic and mediastinal disorders       
Pneumonia/Respiratory Infection   2/67 (2.99%)  2 4/69 (5.80%)  5 1/69 (1.45%)  1
Indicates events were collected by systematic assessment
[1]
Acute alcohol intoxication treated in the Emergency Dept or inpatient hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ondansetron - Sugar Pill Low Dose Ondansetron (0.2 mg Bid) Moderate Dose Ondansetron (0.8 mg Bid)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/67 (10.45%)      5/69 (7.25%)      8/69 (11.59%)    
General disorders       
Other   1/67 (1.49%)  1 2/69 (2.90%)  2 1/69 (1.45%)  1
Psychiatric disorders       
Alcohol intoxication/withdrawal   2/67 (2.99%)  2 1/69 (1.45%)  1 1/69 (1.45%)  1
Respiratory, thoracic and mediastinal disorders       
Cough/cold symptoms   3/67 (4.48%)  3 2/69 (2.90%)  2 4/69 (5.80%)  4
Skin and subcutaneous tissue disorders       
Rash/wound infection   1/67 (1.49%)  1 0/69 (0.00%)  0 2/69 (2.90%)  2
Indicates events were collected by systematic assessment
Drinking data are based on patient self-report.
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
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