Trial · NCT00218062

Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

NCT00218062, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2017-06-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals. Trials, record NCT00218062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00218062

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Trial

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

Title: Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
NCT number: NCT00218062
Status: Completed
Phases: Phase 2
Enrollment: 73 participants, actual
Lead sponsor: The University of Texas Health Science Center, Houston
Conditions: Cocaine-Related Disorders
Interventions: D-Amphetamine 30mg, D-Amphetamine 60mg, Modafinil 200mg, Modafinil 400mg, Therapy, Placebo
First posted: 2005-09-22
Last updated: 2017-06-21
Results first posted: 2017-06-21
Limitations and caveats: High attrition; Pill-taking burden (3 capsules daily) contributed to medication non-compliance; Small sample size.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame
Primary	Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	16 weeks
Primary	Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	16 weeks
Primary	Retention as Indicated by the Number of Participants Who Remained in the Study	16 weeks
Secondary	Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report	16 weeks
Secondary	Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples	16 weeks

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	16 weeks	All participants who received the first dose of study medication were included in this analysis.	number of cocaine negative urines	MEAN
PRIMARY	Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	16 weeks		participants	NUMBER
PRIMARY	Retention as Indicated by the Number of Participants Who Remained in the Study	16 weeks		participants	NUMBER
SECONDARY	Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report	16 weeks		percentage of pills taken	NUMBER
SECONDARY	Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples	16 weeks		% of riboflavin-positive urine samples	NUMBER

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	D-Amphetamine 60mg + Therapy	9.25	Standard Deviation 13.45	number of cocaine negative urines
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	Modafinil 400mg + Therapy	6.09	Standard Deviation 8.12	number of cocaine negative urines
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	Modafinil 200mg + D-Amphetamine 30mg + Therapy	6	Standard Deviation 7.73	number of cocaine negative urines
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment	Placebo + Therapy	4.91	Standard Deviation 7.56	number of cocaine negative urines
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	D-Amphetamine 60mg + Therapy	7		participants
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	Modafinil 400mg + Therapy	4		participants
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	Modafinil 200mg + D-Amphetamine 30mg + Therapy	3		participants
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment	Placebo + Therapy	3		participants
Retention as Indicated by the Number of Participants Who Remained in the Study	D-Amphetamine 60mg + Therapy	7		participants
Retention as Indicated by the Number of Participants Who Remained in the Study	Modafinil 400mg + Therapy	4		participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	D-Amphetamine 60mg + Therapy	22
Overall Study	STARTED	Modafinil 400mg + Therapy	20
Overall Study	STARTED	Modafinil 200mg + D-Amphetamine 30mg + Therapy	15
Overall Study	STARTED	Placebo + Therapy	16
Overall Study	Received First Dose of Study Medication	D-Amphetamine 60mg + Therapy	16
Overall Study	Received First Dose of Study Medication	Modafinil 400mg + Therapy	11
Overall Study	Received First Dose of Study Medication	Modafinil 200mg + D-Amphetamine 30mg + Therapy	10
Overall Study	Received First Dose of Study Medication	Placebo + Therapy	12
Overall Study	COMPLETED	D-Amphetamine 60mg + Therapy	7
Overall Study	COMPLETED	Modafinil 400mg + Therapy	4

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events20

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	Chest pain	Cardiac disorders	D-Amphetamine 60mg + Therapy	1	22	1
other	Chest pain	Cardiac disorders	Modafinil 400mg + Therapy	1	20	1
other	Chest pain	Cardiac disorders	Modafinil 200mg + D-Amphetamine 30mg + Therapy	0	15	0
other	Chest pain	Cardiac disorders	Placebo + Therapy	0	16	0
other	Pneumonia	Infections and infestations	D-Amphetamine 60mg + Therapy	0	22	0
other	Pneumonia	Infections and infestations	Modafinil 400mg + Therapy	1	20	1
other	Pneumonia	Infections and infestations	Modafinil 200mg + D-Amphetamine 30mg + Therapy	0	15	0
other	Pneumonia	Infections and infestations	Placebo + Therapy	0	16	0
other	Migraine	Vascular disorders	D-Amphetamine 60mg + Therapy	0	22	0
other	Migraine	Vascular disorders	Modafinil 400mg + Therapy	1	20	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	D-Amphetamine 60mg + Therapy
Total, all-cause mortality	Modafinil 400mg + Therapy
Total, all-cause mortality	Modafinil 200mg + D-Amphetamine 30mg + Therapy
Total, all-cause mortality	Placebo + Therapy
Total, other adverse events	D-Amphetamine 60mg + Therapy	1	22
Total, other adverse events	Modafinil 400mg + Therapy	3	20
Total, other adverse events	Modafinil 200mg + D-Amphetamine 30mg + Therapy	2	15
Total, other adverse events	Placebo + Therapy	0	16
Total, serious adverse events	D-Amphetamine 60mg + Therapy	0	22
Total, serious adverse events	Modafinil 400mg + Therapy	0	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22969732	RESULT

Source 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
P50DA009262	Substance Abuse Research - Medications Development Center	SCHMITZ, JOY MARIE	UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON	NATIONAL INSTITUTE ON DRUG ABUSE	1994 to 2014

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.

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