New Medication Treatment for Stimulant Dependence

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00689572
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 108
• Locations: 2
• Arms: 2
• Duration (Months): 65
• Patients Per Site: 54
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Ondansetron; Drug: Placebo	Phase 2

Detailed Description

We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: New Medication Treatment for Stimulant Dependence
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Drug: Ondansetron; 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy; Other Names: Zofran
Placebo Comparator: Placebo Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Drug: Placebo; twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy; Other Names: Sugar Pill

Outcome Measures

Primary Outcome Measures

1. Cocaine Use by Self-report [up to 9 weeks]

   Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report

2. Cocaine Use by Urine Benzoylecgonine [up to 9 weeks]

   Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females who have given written informed consent.

• Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.

• Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.

• Current DSM-IV diagnosis of cocaine dependence.

• At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.

• The pregnancy test for females at intake must be negative.

• Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.

• Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.

• Willing to participate in behavioral treatments for cocaine dependence.

Exclusion Criteria:

Please contact site for additional information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Center for Addiction Research and Education	Charlottesville	Virginia	United States	22911
2	University of Virginia Center for Addiction Research and Education	Richmond	Virginia	United States	23294

Sponsors and Collaborators

• University of Virginia
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Nassima Ait-Daoud Tiouririne, M.D., University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (UVA CARE Website)

Publications

None provided.

• Responsible Party: Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Addiction Research and Education, University of Virginia
• ClinicalTrials.gov Identifier: NCT00689572
• Other Study ID Numbers: 13419; 1R01DA021776-01A1
• First Posted: Jun 3, 2008
• Last Update Posted: Nov 11, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Addiction Research and Education, University of Virginia: cocaine dependence; cocaine abuse; cocaine; crack
• Additional relevant MeSH terms: Cocaine-Related Disorders; Ondansetron

Study Results

Participant Flow

Arm/Group Title	Ondansetron	Placebo
Arm/Group Description	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Period Title: Overall Study
STARTED	53	55
COMPLETED	39	34
NOT COMPLETED	14	21

Baseline Characteristics

Arm/Group Title	Ondansetron	Placebo	Total
Arm/Group Description	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Total of all reporting groups
Overall Participants	53	55	108
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	53 100%	55 100%	108 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	20 37.7%	22 40%	42 38.9%
Male	33 62.3%	33 60%	66 61.1%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	12 22.6%	9 16.4%	21 19.4%
American Indian or Alaskan Native	0 0%	0 0%	0 0%
Asian American or Pacific Islander	0 0%	0 0%	0 0%
Black or African American	40 75.5%	45 81.8%	85 78.7%
Hispanic	0 0%	0 0%	0 0%
Other	1 1.9%	1 1.8%	2 1.9%
Region of Enrollment (participants) [Number]
United States	53 100%	55 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Cocaine Use by Self-report
Description	Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Time Frame	up to 9 weeks

Outcome Measure Data

Analysis Population Description

All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.

Arm/Group Title	Ondansetron	Placebo
Arm/Group Description	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Measure Participants	53	55
Mean (Standard Deviation) [Percent of cocaine-free (abstinent)days]	67 (0.25)	67 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ondansetron, Placebo
	Comments	Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)
	Type of Statistical Test	Equivalence
	Comments	Mixed-effects linear regression model
Statistical Test of Hypothesis	p-Value	0.972
	Comments
	Method	Regression, Linear
	Comments	Mixed-effects linear regression model included random intercept and slope (for temporal trend)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -5.43 to 5.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Cocaine Use by Urine Benzoylecgonine
Description	Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Time Frame	up to 9 weeks

Outcome Measure Data

Analysis Population Description

All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.

Arm/Group Title	Ondansetron	Placebo
Arm/Group Description	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy	Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Measure Participants	53	55
Mean (Standard Deviation) [Percent of cocaine-free urines]	16 (0.32)	26 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ondansetron, Placebo
	Comments	Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)
	Type of Statistical Test	Equivalence
	Comments	Mixed-effects linear regression model
Statistical Test of Hypothesis	p-Value	0.909
	Comments
	Method	Regression, Linear
	Comments	Mixed-effects linear regression model included random intercept and slope (for temporal trend)
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; -7.08 to 7.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	up to 9 weeks
Arm/Group Title	Ondansetron		Placebo
Arm/Group Description	Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy		Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
All Cause Mortality
	Ondansetron		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/55 (0%)
Serious Adverse Events
	Ondansetron		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)		1/55 (1.8%)
Hepatobiliary disorders
Hospitalization for gallstone	1/53 (1.9%)	1	0/55 (0%)	0
Surgical and medical procedures
Hospialization for stab wound to chest	0/53 (0%)	0	1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	Ondansetron		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/53 (83%)		47/55 (85.5%)
Gastrointestinal disorders
Abdominal Pain	19/53 (35.8%)		14/55 (25.5%)
Appetite Increase	18/53 (34%)		12/55 (21.8%)
Appetite Decrease	18/53 (34%)		17/55 (30.9%)
Constipation	34/53 (64.2%)		16/55 (29.1%)
Diarrhea	16/53 (30.2%)		25/55 (45.5%)
Vomiting	13/53 (24.5%)		11/55 (20%)
Nausea	15/53 (28.3%)		14/55 (25.5%)
Metabolism and nutrition disorders
Weight Decrease	3/53 (5.7%)		2/55 (3.6%)
Weight Increase	1/53 (1.9%)		1/55 (1.8%)
Musculoskeletal and connective tissue disorders
Back pain	3/53 (5.7%)		5/55 (9.1%)
Nervous system disorders
Dizziness	5/53 (9.4%)		9/55 (16.4%)
Fatigue	26/53 (49.1%)		13/55 (23.6%)
Headache	23/53 (43.4%)		24/55 (43.6%)
Insomnia	18/53 (34%)		24/55 (43.6%)
Paresthesia	3/53 (5.7%)		3/55 (5.5%)
Psychiatric disorders
Anxiety	7/53 (13.2%)		11/55 (20%)
Depression	2/53 (3.8%)		1/55 (1.8%)
Somnolence	21/53 (39.6%)		8/55 (14.5%)
Skin and subcutaneous tissue disorders
Rash	7/53 (13.2%)		10/55 (18.2%)

Limitations/Caveats

[Not Specified]

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.