Trial · NCT01641159

Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence

NCT01641159, Phase 2, Completed, University of Cincinnati; results first posted 2014-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence. Trials, record NCT01641159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01641159

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence
NCT number: NCT01641159
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: University of Cincinnati
Conditions: Cocaine Dependence
Interventions: Buspirone, Placebo
First posted: 2012-07-16
Last updated: 2015-01-07
Results first posted: 2014-12-17

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Days of Continuous Cocaine Abstinence	study week 16	The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.
Secondary	Cocaine-use Days	study week 16	Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Days of Continuous Cocaine Abstinence	study week 16		Days	MEAN
SECONDARY	Cocaine-use Days	study week 16	All randomized participants	proportion of cocaine use days	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Days of Continuous Cocaine Abstinence	Buspirone Plus TAU	42.9	Standard Deviation 30.83	Days
Maximum Days of Continuous Cocaine Abstinence	Placebo Plus TAU	46.6	Standard Deviation 31.03	Days
Cocaine-use Days	Buspirone Plus TAU	0.153		proportion of cocaine use days
Cocaine-use Days	Placebo Plus TAU	0.134		proportion of cocaine use days

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Buspirone Plus TAU	35
Overall Study	STARTED	Placebo Plus TAU	27
Overall Study	COMPLETED	Buspirone Plus TAU	33
Overall Study	COMPLETED	Placebo Plus TAU	25
Overall Study	NOT COMPLETED	Buspirone Plus TAU	2
Overall Study	NOT COMPLETED	Placebo Plus TAU	2

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Buspirone Plus TAU	15	35	18
other	Dizziness	Nervous system disorders	Placebo Plus TAU	1	27	1
other	Headache	Nervous system disorders	Buspirone Plus TAU	8	35	8
other	Headache	Nervous system disorders	Placebo Plus TAU	7	27	8
other	Somnolence	Nervous system disorders	Buspirone Plus TAU	3	35	3
other	Somnolence	Nervous system disorders	Placebo Plus TAU	2	27	2
other	Nasopharyngitis	Infections and infestations	Buspirone Plus TAU	8	35	8
other	Nasopharyngitis	Infections and infestations	Placebo Plus TAU	4	27	6
other	Upper respiratory tract infection	Infections and infestations	Buspirone Plus TAU	2	35	2
other	Upper respiratory tract infection	Infections and infestations	Placebo Plus TAU	2	27	2

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Buspirone Plus TAU
Total, all-cause mortality	Placebo Plus TAU
Total, other adverse events	Buspirone Plus TAU	18	35
Total, other adverse events	Placebo Plus TAU	11	27
Total, serious adverse events	Buspirone Plus TAU	3	35
Total, serious adverse events	Placebo Plus TAU	0	27

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22613054	BACKGROUND	PubMed
24911028	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10DA013732	Clinical Trials Network, Ohio Valley Node U10DA013732	WINHUSEN, T JOHN	UNIVERSITY OF CINCINNATI	NATIONAL INSTITUTE ON DRUG ABUSE	2000 to 2015

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Buspirone Plus TAU vs Placebo Plus TAU: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01641159

GET https://conductscience.org/api/trials/v1/NCT01641159/events?page=2

API reference For AI assistants