Trial Outcomes & Findings for New Medication Treatment for Stimulant Dependence (NCT NCT00689572)
NCT ID: NCT00689572
Last Updated: 2021-11-11
Results Overview
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
up to 9 weeks
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
Ondansetron
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
|
Overall Study
COMPLETED
|
39
|
34
|
|
Overall Study
NOT COMPLETED
|
14
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Medication Treatment for Stimulant Dependence
Baseline characteristics by cohort
| Measure |
Ondansetron
n=53 Participants
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
n=55 Participants
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian American or Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
40 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=93 Participants
|
55 participants
n=4 Participants
|
108 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 9 weeksPopulation: All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Outcome measures
| Measure |
Ondansetron
n=53 Participants
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
n=55 Participants
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
|---|---|---|
|
Cocaine Use by Self-report
|
67 Percent of cocaine-free (abstinent)days
Standard Deviation 0.25
|
67 Percent of cocaine-free (abstinent)days
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: up to 9 weeksPopulation: All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Outcome measures
| Measure |
Ondansetron
n=53 Participants
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
n=55 Participants
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
|---|---|---|
|
Cocaine Use by Urine Benzoylecgonine
|
16 Percent of cocaine-free urines
Standard Deviation 0.32
|
26 Percent of cocaine-free urines
Standard Deviation 0.33
|
Adverse Events
Ondansetron
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ondansetron
n=53 participants at risk
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
n=55 participants at risk
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
|---|---|---|
|
Hepatobiliary disorders
Hospitalization for gallstone
|
1.9%
1/53 • Number of events 1 • up to 9 weeks
|
0.00%
0/55 • up to 9 weeks
|
|
Surgical and medical procedures
Hospialization for stab wound to chest
|
0.00%
0/53 • up to 9 weeks
|
1.8%
1/55 • Number of events 1 • up to 9 weeks
|
Other adverse events
| Measure |
Ondansetron
n=53 participants at risk
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
Placebo
n=55 participants at risk
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
35.8%
19/53 • up to 9 weeks
|
25.5%
14/55 • up to 9 weeks
|
|
Psychiatric disorders
Anxiety
|
13.2%
7/53 • up to 9 weeks
|
20.0%
11/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Appetite Increase
|
34.0%
18/53 • up to 9 weeks
|
21.8%
12/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Appetite Decrease
|
34.0%
18/53 • up to 9 weeks
|
30.9%
17/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
64.2%
34/53 • up to 9 weeks
|
29.1%
16/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
30.2%
16/53 • up to 9 weeks
|
45.5%
25/55 • up to 9 weeks
|
|
Nervous system disorders
Dizziness
|
9.4%
5/53 • up to 9 weeks
|
16.4%
9/55 • up to 9 weeks
|
|
Nervous system disorders
Fatigue
|
49.1%
26/53 • up to 9 weeks
|
23.6%
13/55 • up to 9 weeks
|
|
Nervous system disorders
Headache
|
43.4%
23/53 • up to 9 weeks
|
43.6%
24/55 • up to 9 weeks
|
|
Nervous system disorders
Insomnia
|
34.0%
18/53 • up to 9 weeks
|
43.6%
24/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
24.5%
13/53 • up to 9 weeks
|
20.0%
11/55 • up to 9 weeks
|
|
Metabolism and nutrition disorders
Weight Decrease
|
5.7%
3/53 • up to 9 weeks
|
3.6%
2/55 • up to 9 weeks
|
|
Metabolism and nutrition disorders
Weight Increase
|
1.9%
1/53 • up to 9 weeks
|
1.8%
1/55 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.2%
7/53 • up to 9 weeks
|
18.2%
10/55 • up to 9 weeks
|
|
Nervous system disorders
Paresthesia
|
5.7%
3/53 • up to 9 weeks
|
5.5%
3/55 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
3/53 • up to 9 weeks
|
9.1%
5/55 • up to 9 weeks
|
|
Psychiatric disorders
Depression
|
3.8%
2/53 • up to 9 weeks
|
1.8%
1/55 • up to 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
28.3%
15/53 • up to 9 weeks
|
25.5%
14/55 • up to 9 weeks
|
|
Psychiatric disorders
Somnolence
|
39.6%
21/53 • up to 9 weeks
|
14.5%
8/55 • up to 9 weeks
|
Additional Information
Nassima Ait-Daoud Tiouririne, M.D.
University of Virginia
Phone: (434)243-0570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place