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| Sponsor: | University of Texas |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00218036 |
Purpose
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Abuse Opiate Dependence |
Drug: Modafinil 200mg Drug: Modafinil 400mg Drug: Citalopram 20mg Drug: Citalopram 40mg Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
|
Drug: Modafinil 200mg
10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
|
|
2: Experimental
Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
|
Drug: Modafinil 400mg
10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
|
|
3: Experimental
Citalopram 20/ Methadone Maintenance 1.2mg/kg
|
Drug: Citalopram 20mg
10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
|
|
4: Experimental
Citalopram 40/ Methadone Maintenance 1.2 mg/kg
|
Drug: Citalopram 40mg
10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
|
|
5: Placebo Comparator
Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
|
Drug: Placebo
Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
|
This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.
Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.
Eligibility| Ages Eligible for Study: | 22 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Laura B Madden-Fuentes, B.A. | 713-500-2563 | Laura.MaddenFuentes@uth.tmc.edu |
| Contact: Ann Garcia, MA | 713-500-2804 | Ann.D.Garcia@uth.tmc.edu |
| United States, Texas | |
| University of Texas Health Science Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu | |
| Principal Investigator: Richard Meisch, MD, PhD | |
| Principal Investigator: | Joy M Schmitz, PhD | University of Texas |
| Study Chair: | F. Gerard Moeller, M.D. | University of Texas Medical School at Houston |
More Information
| Responsible Party: | University of Texas Medical School at Houston ( Joy Schmitz, Ph.D. ) |
| Study ID Numbers: | NIDA-09262-8, P50DA009262-08, DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | December 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00218036 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
Cocaine Abuse Opiate Abuse |
|
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Anesthetics Disorders of Environmental Origin Antiparkinson Agents Cholinergic Agents Opioid-Related Disorders Neuroprotective Agents |
Modafinil Sensory System Agents Mental Disorders Therapeutic Uses Vasoconstrictor Agents Substance-Related Disorders Antidepressive Agents, Second-Generation Cocaine Dexetimide Antidepressive Agents Cocaine-Related Disorders Central Nervous System Depressants Central Nervous System Stimulants Cardiovascular Agents Protective Agents |
