Trial · NCT00469508

Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

NCT00469508, Phase 2, Completed, University of California, Los Angeles; results first posted 2013-03-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Modafinil vs Placebo for the Treatment of Methamphetamine Dependence. Trials, record NCT00469508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00469508

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Trial

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

Title: Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
NCT number: NCT00469508
Status: Completed
Phases: Phase 2
Enrollment: 71 participants, actual
Lead sponsor: University of California, Los Angeles
Conditions: Methamphetamine Dependence
Interventions: Modafinil, Placebo
First posted: 2007-05-04
Last updated: 2020-03-02
Results first posted: 2013-03-15
Limitations and caveats: study is powered to detect at least a moderate effect for modafinil (d = 0.50) in the overall sample; subgroups may be more meaningful

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Clean Urine Drug Screen	From randomization to end of week 12	Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.
Secondary	Retention	12 weeks	The number of persons who completed the medication phase of the trial (12 weeks of medication).
Other	VAS Score	baseline and last observation during the 12 week treatment period	To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.
Other	BDI Score	From baseline to end of treatment period (week 12).	Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clean Urine Drug Screen	From randomization to end of week 12	Intention to treat	Clean urine drug screens	MEAN
SECONDARY	Retention	12 weeks	Intention to treat	participants	NUMBER
OTHER_PRE_SPECIFIED	VAS Score	baseline and last observation during the 12 week treatment period	Intention to treat, LOCF	units on a scale	MEAN
OTHER_PRE_SPECIFIED	BDI Score	From baseline to end of treatment period (week 12).	Intention to treat, LOCF	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Clean Urine Drug Screen	Modafinil	13.1	Standard Deviation 11.5	Clean urine drug screens
Clean Urine Drug Screen	Placebo	12.7	Standard Deviation 13.2	Clean urine drug screens
Retention	Modafinil	14		participants
Retention	Placebo	13		participants
VAS Score	Modafinil	-32.5	Standard Deviation 33.8	units on a scale
VAS Score	Placebo	-47.3	Standard Deviation 32.6	units on a scale
BDI Score	Modafinil	-11.8	Standard Deviation 12.9	units on a scale
BDI Score	Placebo	-7	Standard Deviation 11.2	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Modafinil	34
Overall Study	STARTED	Placebo	37
Overall Study	COMPLETED	Modafinil	14
Overall Study	COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Modafinil	20
Overall Study	NOT COMPLETED	Placebo	24

Source ClinicalTrials.gov

Adverse events194

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	Abdominal Pain	Gastrointestinal disorders	Modafinil	0	34	0
other	Abdominal Pain	Gastrointestinal disorders	Placebo	1	37	1
other	Abscess Gum	Infections and infestations	Modafinil	1	34	1
other	Abscess Gum	Infections and infestations	Placebo	0	37	0
other	Agitation	General disorders	Modafinil	1	34	1
other	Agitation	General disorders	Placebo	1	37	1
other	Anger	Psychiatric disorders	Modafinil	1	34	1
other	Anger	Psychiatric disorders	Placebo	0	37	0
other	Anxiety	General disorders	Modafinil	5	34	5
other	Anxiety	General disorders	Placebo	1	37	1

1 to 10 of 194Source ClinicalTrials.gov

See all 194 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Modafinil
Total, all-cause mortality	Placebo
Total, other adverse events	Modafinil	33	34
Total, other adverse events	Placebo	36	37
Total, serious adverse events	Modafinil	3	34
Total, serious adverse events	Placebo	1	37

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20092966	RESULT	PubMed
22217949	RESULT	PubMed
22445683	RESULT	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
P50DA018185	UCLA Medication Development Unit for Stimulant Abuse	SHOPTAW, STEVEN J	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE ON DRUG ABUSE	2004 to 2009

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Modafinil vs Placebo: Retention	Trial comparisons
Modafinil vs Placebo: serious adverse events	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/NCT00469508

GET https://conductscience.org/api/trials/v1/NCT00469508/events?page=2

API reference For AI assistants