Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
3 other identifiers
interventional
73
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
June 21, 2017
CompletedJune 21, 2017
May 1, 2017
5.8 years
September 16, 2005
May 24, 2017
May 24, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
16 weeks
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
16 weeks
Retention as Indicated by the Number of Participants Who Remained in the Study
16 weeks
Secondary Outcomes (2)
Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
16 weeks
Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
16 weeks
Study Arms (4)
D-Amphetamine 60mg + Therapy
EXPERIMENTALDuring 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.
Modafinil 400mg + Therapy
EXPERIMENTALDuring 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.
Modafinil 200mg + D-Amphetamine 30mg + Therapy
EXPERIMENTALDuring 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.
Placebo + Therapy
PLACEBO COMPARATORDuring 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center
Houston, Texas, 77030, United States
Related Publications (1)
Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.
PMID: 22969732RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
High attrition; Pill-taking burden (3 capsules daily) contributed to medication non-compliance; Small sample size.
Results Point of Contact
- Title
- Dr Joy M. Schmitz
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Joy M. Schmitz, PhD
University of Texas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor - PSY-Behavioral Sciences
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
March 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
June 21, 2017
Results First Posted
June 21, 2017
Record last verified: 2017-05