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

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders
Drug: Dextro amphetamine sulfate and Modafinil
Drug: modafinil
Drug: Modafinil 400 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Substance use [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 73
Study Start Date: March 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Modafinil 200mg
Drug: modafinil
10 day medication run-up of modafinil from 0-200mg
Experimental: 3
Modafinil 400mg
Drug: Modafinil 400 mg
10 day run up to 400mg of modafinil
Experimental: 1
Modafinil 200mg/ D-Amphetamine 30mg
Drug: Dextro amphetamine sulfate and Modafinil
d-amphetamine 30mg / modafinil 200mg
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218062

Locations
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Joy M. Schmitz, PhD University of Texas
  More Information

No publications provided

Responsible Party: Joy Schmitz, Professor - PSY-Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00218062     History of Changes
Other Study ID Numbers: NIDA-09262-12, P50DA009262-12, DPMC
Study First Received: September 16, 2005
Last Updated: March 2, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Amphetamine
Armodafinil
Dextroamphetamine
Modafinil
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on October 23, 2014