CompletedNCT00520286Updated Apr 7, 2017Results posted

Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

A Phase 2 interventional study of Modafinil and Placebo in Methamphetamine Dependence, sponsored by National Institute on Drug Abuse (NIDA). Completed at 8 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 210
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Read the detailed description

To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.

Conditions studied

Methamphetamine Dependence

Keywords

Methamphetamine Dependence

In context

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Must be between the ages of 18 and 65
Methamphetamine dependent as defined by DSM-IV criteria
Must be in good general heath with a history of methamphetamine use at screening
Must be able to provide written informed consent
If female and of child bearing potential, must agree to use birth control.

Exclusion criteria

Exclusion Criteria:

Please contact site for more information

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 210 participants (actual)

Study arms

Active comparator
Modafinil
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Modafinil
Placebo comparator
Placebo
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Drug: Placebo

Interventions

DrugModafinil
200 mg or 400 mg /daily
DrugPlacebo
Placebo / daily

What researchers measure

Primary outcomes

Abstinence (Week 1 - 12)
Number of participant who abstained from methamphetamine from weeks 1 through 12
Time frame: Weeks 1 - 12

Secondary outcomes

Reduction of Craving
Number of subjects with 21 or more consecutive days of abstinence
Time frame: 21 days

Results

Posted Apr 7, 2017

Participant flow

Participant flow — Overall Study
Milestone	Modafinil	Placebo
Started	142	68
Completed	76	36
Not completed	66	32

Outcome measures

PrimaryAbstinence (Week 1 - 12)

Number of participant who abstained from methamphetamine from weeks 1 through 12

Time frame:: Weeks 1 - 12
Reported as:: Count of participants · Participants

Abstinence (Week 1 - 12)
Participants	Modafinil	Placebo
Week 1	27	14
Week 2	38	13
Week 3	39	13
Week 4	46	15
Week 5	41	16
Week 6	39	15
Week 7	34	14
Week 8	40	16
Week 9	35	17
Week 10	34	14
Week 11	37	16
Week 12	34	17

SecondaryReduction of Craving

Number of subjects with 21 or more consecutive days of abstinence

Time frame:: 21 days
Reported as:: Count of participants · Participants

Reduction of Craving
Participants	Modafinil	Placebo
Reduction of Craving	32	10

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Modafinil	—	0/142 (0%)	128/142 (90.1%)
Placebo	—	5/68 (7.4%)	54/68 (79.4%)

Most frequent serious events

Most frequent serious events
Event	Modafinil	Placebo
Leg infectionInfections and infestations	0/142	1/68
Suicidal IdeationPsychiatric disorders	0/142	1/68
chest painCardiac disorders	0/142	1/68
CelluitisSkin and subcutaneous tissue disorders	0/142	1/68
Compartment syndrome left forearmMusculoskeletal and connective tissue disorders	0/142	1/68

Most frequent other events

Most frequent other events
Event	Modafinil	Placebo
HeadacheNervous system disorders	60/142	30/68
HypertensionVascular disorders	55/142	23/68
NauseaGastrointestinal disorders	23/142	8/68

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Modafinil	Placebo	Total
Mean	77.6 ± 17.3	39 ± 8.6	39 ± 8.6

Sex: Female, Male
Sex: Female, Male(Participants)	Modafinil	Placebo	Total
Female	56	30	86
Male	86	38	124

Region of Enrollment
Region of Enrollment(participants)	Modafinil	Placebo	Total
United States	142	68	210

Study locations

8 sites

South Bay Treatment Center
San Diego, California 92105, United States
Matrix Institute on Addictions
Tarzana, California 91356, United States
Torrance Site
Torrance, California 90502, United States
University of Colorado Health Sciences Center
Denver, Colorado 80220, United States
John A. Burns School of Medicine
Honolulu, Hawaii 96813, United States
Powell Chemical Dependency Center
Des Moines, Iowa 50316, United States
START Research and Treatment
Kansas City, Missouri 64131, United States
Salt Lake City VA Medical Center
Salt Lake City, Utah 84148, United States

References and documents

Publications

Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12. PubMed 21840138 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00520286
Lead sponsor: National Institute on Drug Abuse (NIDA)
Collaborators: VA Office of Research and Development
Responsible party: Sponsor
First posted: Aug 24, 2007
Start date: Dec 2007
Primary completion: Dec 2009
Completion: Mar 2010
Results posted: Apr 7, 2017
Last update: Apr 7, 2017

Study contacts

Ahmed Elkashef, M.D.

principal investigator · National Institute on Drug Abuse (NIDA)

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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