Trial · NCT00218387

Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

NCT00218387, Phase 2, Completed, Medical University of South Carolina; results first posted 2019-04-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1. Trials, record NCT00218387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00218387

On this page

Trial

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

Title: Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
NCT number: NCT00218387
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Cocaine Dependence
Interventions: Modafinil, Modafinil, Matching Placebo
First posted: 2005-09-22
Last updated: 2019-04-10
Results first posted: 2019-04-10

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Cocaine Non-use Days	8 weeks	Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Primary	Percent of Participants With New Use	8 weeks	New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.

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	Number of Cocaine Non-use Days	8 weeks	The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.	Number of Days	MEAN
PRIMARY	Percent of Participants With New Use	8 weeks	The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Number of Cocaine Non-use Days	200mg Modafinil	No Alcohol Dependence	10.1	Standard Error 2.4	Number of Days
Number of Cocaine Non-use Days	400mg Modafinil	No Alcohol Dependence	17.1	Standard Error 2.3	Number of Days
Number of Cocaine Non-use Days	Matching Placebo	No Alcohol Dependence	9.3	Standard Error 2.7	Number of Days
Number of Cocaine Non-use Days	200mg Modafinil	Alcohol Dependence	14.1	Standard Error 2.5	Number of Days
Number of Cocaine Non-use Days	400mg Modafinil	Alcohol Dependence	9.4	Standard Error 2.5	Number of Days
Number of Cocaine Non-use Days	Matching Placebo	Alcohol Dependence	12.8	Standard Error 2.4	Number of Days
Percent of Participants With New Use	200mg Modafinil	No Alcohol Dependence	54.2		Percentage of participants
Percent of Participants With New Use	400mg Modafinil	No Alcohol Dependence	42.0		Percentage of participants
Percent of Participants With New Use	Matching Placebo	No Alcohol Dependence	55.8		Percentage of participants
Percent of Participants With New Use	200mg Modafinil	Alcohol Dependence	39.7		Percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	200mg Modafinil	40
Overall Study	STARTED	400mg Modafinil	43
Overall Study	STARTED	Matching Placebo	40
Overall Study	COMPLETED	200mg Modafinil	25
Overall Study	COMPLETED	400mg Modafinil	25
Overall Study	COMPLETED	Matching Placebo	17
Overall Study	NOT COMPLETED	200mg Modafinil	15
Overall Study	NOT COMPLETED	400mg Modafinil	18
Overall Study	NOT COMPLETED	Matching Placebo	23

Source ClinicalTrials.gov

Adverse events45

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	Heart Racing	Cardiac disorders	200mg Modafinil	5	40	5
other	Heart Racing	Cardiac disorders	400mg Modafinil	5	43	6
other	Heart Racing	Cardiac disorders	Matching Placebo	1	40	1
other	Numbness	Nervous system disorders	200mg Modafinil	1	40	1
other	Numbness	Nervous system disorders	400mg Modafinil	2	43	3
other	Numbness	Nervous system disorders	Matching Placebo	1	40	1
other	Irritability	Psychiatric disorders	200mg Modafinil	0	40	0
other	Irritability	Psychiatric disorders	400mg Modafinil	0	43	0
other	Irritability	Psychiatric disorders	Matching Placebo	2	40	2
other	Headache	Nervous system disorders	200mg Modafinil	13	40	17

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	200mg Modafinil
Total, all-cause mortality	400mg Modafinil
Total, all-cause mortality	Matching Placebo
Total, other adverse events	200mg Modafinil	33	40
Total, other adverse events	400mg Modafinil	34	43
Total, other adverse events	Matching Placebo	27	40
Total, serious adverse events	200mg Modafinil	0	40
Total, serious adverse events	400mg Modafinil	0	43
Total, serious adverse events	Matching Placebo	0	40

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
R01DA016368	CBT and Modafinil for Cocaine Addiction	MALCOLM, ROBERT JAMES	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON DRUG ABUSE	2003 to 2009

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00218387

GET https://conductscience.org/api/trials/v1/NCT00218387/events?page=2

API reference For AI assistants