Trial · NCT00129285

Modafinil Treatment for Cocaine-Dependent Individuals

NCT00129285, Phase 2, Completed, University of Pennsylvania; results first posted 2018-05-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Modafinil Treatment for Cocaine-Dependent Individuals. Trials, record NCT00129285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00129285

On this page

Trial

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

Title: Modafinil Treatment for Cocaine-Dependent Individuals
NCT number: NCT00129285
Status: Completed
Phases: Phase 2
Enrollment: 210 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Cocaine-Related Disorders
Interventions: Low Dose Modafinil, High Dose Modafinil, Placebo
First posted: 2005-08-11
Last updated: 2018-05-08
Results first posted: 2018-05-08

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Urine Toxicology for Cocaine	3 weeks	Abstinent in the final 3 weeks of treatment
Secondary	Retention; Number of Evaluation Visits Attended	8 weeks	Number of visits attended compared between the three conditions using anova
Secondary	Cocaine Selective Severity Assessment (CSSA) Total Score	8 weeks	Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Urine Toxicology for Cocaine	3 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Retention; Number of Evaluation Visits Attended	8 weeks		number of evaluation sessions attended	MEAN
SECONDARY	Cocaine Selective Severity Assessment (CSSA) Total Score	8 weeks	patients exposed to low dose and high dose modafinil	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Urine Toxicology for Cocaine	Low Dose Modafinil	3		Participants
Urine Toxicology for Cocaine	High Dose Modafinil	8		Participants
Urine Toxicology for Cocaine	Placebo	3		Participants
Retention; Number of Evaluation Visits Attended	1Low Dose Modafinil	16.8	Standard Deviation 7.1	number of evaluation sessions attended
Retention; Number of Evaluation Visits Attended	2 High Dose Modafinil	16.5	Standard Deviation 6.7	number of evaluation sessions attended
Retention; Number of Evaluation Visits Attended	3. Placebo	14.3	Standard Deviation 7.1	number of evaluation sessions attended
Cocaine Selective Severity Assessment (CSSA) Total Score	Low Dose Modafinil	12.89	Standard Deviation 11.70	units on a scale
Cocaine Selective Severity Assessment (CSSA) Total Score	High Dose Modafinil	15.04	Standard Deviation 13.52	units on a scale
Cocaine Selective Severity Assessment (CSSA) Total Score	Placebo	15.2	Standard Deviation 14.32	units on a scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose Modafinil	65
Overall Study	STARTED	High Dose Modafinil	70
Overall Study	STARTED	Placebo	75
Overall Study	COMPLETED	Low Dose Modafinil	40
Overall Study	COMPLETED	High Dose Modafinil	43
Overall Study	COMPLETED	Placebo	37
Overall Study	NOT COMPLETED	Low Dose Modafinil	25
Overall Study	NOT COMPLETED	High Dose Modafinil	27
Overall Study	NOT COMPLETED	Placebo	38

Source ClinicalTrials.gov

Adverse events39

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
other	Headache	General disorders	Modafinil High Dose	15	70
other	Headache	General disorders	Placebo	14	75
other	Headache	General disorders	Modafinil Low Dose	11	65
other	Body Aches	Musculoskeletal and connective tissue disorders	Modafinil High Dose	23	70
other	Body Aches	Musculoskeletal and connective tissue disorders	Placebo	27	75
other	Body Aches	Musculoskeletal and connective tissue disorders	Modafinil Low Dose	17	65
other	Upper respiratory tract infection	Infections and infestations	Modafinil High Dose	18	70
other	Upper respiratory tract infection	Infections and infestations	Placebo	22	75
other	Upper respiratory tract infection	Infections and infestations	Modafinil Low Dose	14	65
other	Insomnia	General disorders	Modafinil High Dose	9	70

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Modafinil High Dose
Total, all-cause mortality	Placebo
Total, all-cause mortality	Modafinil Low Dose
Total, other adverse events	Modafinil High Dose	63	70
Total, other adverse events	Placebo	62	75
Total, other adverse events	Modafinil Low Dose	50	65
Total, serious adverse events	Modafinil High Dose	1	70
Total, serious adverse events	Placebo	0	75
Total, serious adverse events	Modafinil Low Dose	0	65

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
R01DA015366	Modafinil Treatment for Cocaine Dependence	DACKIS, CHARLES	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	2004 to 2007

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/NCT00129285

GET https://conductscience.org/api/trials/v1/NCT00129285/events?page=2

API reference For AI assistants