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

Cocaine-Related Disorders Clinical Trial

Official title:

Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218062
• Other study ID #: NIDA-09262-12
• Secondary ID: P50DA009262-12DP
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: March 2, 2012
• Start date: March 2006
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

Description:

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.

This study will last 16 weeks. Participants will be randomly assigned to one of four groups:

1) 200 mg dose of modafinil; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days. Participants assigned to the 400 mg modafinil treatment group will then receive double the initial dose of modafinil for the duration of the study. Participants in the combined group (modafinil and d-amphetamine) will receive 15 and then 30 mg of d-amphetamine over 4 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Meets SCID criteria for cocaine abuse or dependence

• In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.

Exclusion Criteria:

• Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine

• Current cardiovascular disease, as determined by an electrocardiogram

• On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality

• Previously received treatment with d-amphetamine, modafinil, or aripiprazole

• Currently receiving prescribed medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Dextro amphetamine sulfate and Modafinil
d-amphetamine 30mg / modafinil 200mg
• modafinil
10 day medication run-up of modafinil from 0-200mg
• Modafinil 400 mg
10 day run up to 400mg of modafinil
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use		12 weeks of treatment	No
Secondary	Medication compliance		12 weeks of treatment	No
Secondary	medication side effects		12 weeks of treatment	No

External Links

•   Click here for more information about the Treatment Research Clinic at the University of Texas Health Center at Houston