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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: May 24, 2017
Last verified: May 2017
  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: D-Amphetamine 30mg Drug: D-Amphetamine 60mg Drug: Modafinil 200mg Drug: Modafinil 400mg Behavioral: Therapy Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Joy Schmitz, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment [ Time Frame: 16 weeks ]
  • Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment [ Time Frame: 16 weeks ]
  • Retention as Indicated by the Number of Participants Who Remained in the Study [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report [ Time Frame: 16 weeks ]
  • Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples [ Time Frame: 16 weeks ]

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: D-Amphetamine 60mg + Therapy

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Drug: D-Amphetamine 60mg Behavioral: Therapy
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Experimental: Modafinil 400mg + Therapy

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Drug: Modafinil 400mg Behavioral: Therapy
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Experimental: Modafinil 200mg + D-Amphetamine 30mg + Therapy

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Drug: D-Amphetamine 30mg Drug: Modafinil 200mg Behavioral: Therapy
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Placebo Comparator: Placebo + Therapy

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Behavioral: Therapy
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Drug: 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) 60 mg dose of d-amphetamine; 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (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
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joy M. Schmitz, PhD University of Texas
  More Information

Additional Information:
Publications:
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 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Study First Received: September 16, 2005
Results First Received: May 24, 2017
Last Updated: May 24, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Amphetamine
Dextroamphetamine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on August 23, 2017