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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00218062
First received: September 16, 2005
Last updated: March 2, 2012
Last verified: March 2012
History of Changes

September 16, 2005
March 2, 2012
March 2006
January 2012   (final data collection date for primary outcome measure)
Substance use [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
Substance use, retention and medication compliance
Complete list of historical versions of study NCT00218062 on ClinicalTrials.gov Archive Site
  • Medication compliance [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
  • medication side effects [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
Cocaine craving and medication side effects
Not Provided
Not Provided
 
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine-Related Disorders
  • Drug: Dextro amphetamine sulfate and Modafinil
    d-amphetamine 30mg / modafinil 200mg
  • Drug: modafinil
    10 day medication run-up of modafinil from 0-200mg
  • Drug: Modafinil 400 mg
    10 day run up to 400mg of modafinil
  • Drug: Placebo
    Placebo
  • Experimental: 2
    Modafinil 200mg
    Intervention: Drug: modafinil
  • Experimental: 3
    Modafinil 400mg
    Intervention: Drug: Modafinil 400 mg
  • Experimental: 1
    Modafinil 200mg/ D-Amphetamine 30mg
    Intervention: Drug: Dextro amphetamine sulfate and Modafinil
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218062
NIDA-09262-12, P50DA009262-12, DPMC
Yes
Joy Schmitz, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joy M. Schmitz, PhD University of Texas
The University of Texas Health Science Center, Houston
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP