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

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00520286
• Collaborator: VA Office of Research and Development (U.S. Fed)
• Enrollment: 210
• Locations: 8
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 26.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: Modafinil; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Modafinil Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks	Drug: Modafinil; 200 mg or 400 mg /daily
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; Placebo / daily

Outcome Measures

Primary Outcome Measures

1. Abstinence (Week 1 - 12) [Weeks 1 - 12]

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

Secondary Outcome Measures

1. Reduction of Craving [21 days]

   Number of subjects with 21 or more consecutive days of abstinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

• Please contact site for more information

Contacts and Locations

Locations

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

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)
• VA Office of Research and Development

Investigators

• Principal Investigator: Ahmed Elkashef, M.D., National Institute on Drug Abuse (NIDA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT00520286
• Other Study ID Numbers: NIDA-CSP-1026-1
• First Posted: Aug 24, 2007
• Last Update Posted: Apr 7, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by National Institute on Drug Abuse (NIDA): Methamphetamine Dependence
• Additional relevant MeSH terms: Modafinil

Study Results

Participant Flow

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily	Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily
Period Title: Overall Study
STARTED	142	68
COMPLETED	76	36
NOT COMPLETED	66	32

Baseline Characteristics

Arm/Group Title	Modafinil	Placebo	Total
Arm/Group Description	Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily	Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily	Total of all reporting groups
Overall Participants	142	68	210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.6 (17.3)	39 (8.6)	39 (8.6)
Sex: Female, Male (Count of Participants)
Female	56 39.4%	30 44.1%	86 41%
Male	86 60.6%	38 55.9%	124 59%
Region of Enrollment (participants) [Number]
United States	142 100%	68 100%	210 100%

Outcome Measures

1. Primary Outcome

Title	Abstinence (Week 1 - 12)
Description	Number of participant who abstained from methamphetamine from weeks 1 through 12
Time Frame	Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily	Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily
Measure Participants	142	68
Week 1	27 19%	14 20.6%
Week 2	38 26.8%	13 19.1%
Week 3	39 27.5%	13 19.1%
Week 4	46 32.4%	15 22.1%
Week 5	41 28.9%	16 23.5%
Week 6	39 27.5%	15 22.1%
Week 7	34 23.9%	14 20.6%
Week 8	40 28.2%	16 23.5%
Week 9	35 24.6%	17 25%
Week 10	34 23.9%	14 20.6%
Week 11	37 26.1%	16 23.5%
Week 12	34 23.9%	17 25%

2. Secondary Outcome

Title	Reduction of Craving
Description	Number of subjects with 21 or more consecutive days of abstinence
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily	Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily
Measure Participants	142	68
Count of Participants [Participants]	32 22.5%	10 14.7%

Adverse Events

Arm/Group Title	Modafinil		Placebo
Arm/Group Description	Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily		Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily
All Cause Mortality
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/142 (0%)		5/68 (7.4%)
Cardiac disorders
chest pain	0/142 (0%)	0	1/68 (1.5%)	1
Infections and infestations
Leg infection	0/142 (0%)	0	1/68 (1.5%)	1
Musculoskeletal and connective tissue disorders
Compartment syndrome left forearm	0/142 (0%)	0	1/68 (1.5%)	1
Psychiatric disorders
Suicidal Ideation	0/142 (0%)	0	1/68 (1.5%)	1
Skin and subcutaneous tissue disorders
Celluitis	0/142 (0%)	0	1/68 (1.5%)	1
Other (Not Including Serious) Adverse Events
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	128/142 (90.1%)		54/68 (79.4%)
Gastrointestinal disorders
Nausea	23/142 (16.2%)	32	8/68 (11.8%)	13
Nervous system disorders
Headache	60/142 (42.3%)	175	30/68 (44.1%)	63
Vascular disorders
Hypertension	55/142 (38.7%)	104	23/68 (33.8%)	60

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.