Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Texas
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218036
First received: September 16, 2005
Last updated: December 11, 2009
Last verified: December 2009
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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 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 in Cocaine and Opiate Dependent Individuals |
Resource links provided by NLM:
Drug Information available for:
Cocaine hydrochloride
Methadone
Citalopram hydrobromide
Citalopram
Modafinil
Armodafinil
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Retention [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
- Medication Compliance [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
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.
|
|
Experimental: 2
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.
|
|
Experimental: 3
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.
|
|
Experimental: 4
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.
|
|
Placebo Comparator: 5
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
|
Detailed Description:
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 (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Meets cocaine abuse and dependence criteria (as determined by the SCID)
- Meets opiate dependence criteria (as determined by the SCID)
- In good general physical and psychiatric health (except for possible acute drug use related problems)
Exclusion Criteria:
- Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
- Current cardiovascular disease (as determined by an electrocardiogram)
- Circumstances will not allow for completion of study (on probation or parole)
- Ethical constraints of supervision do not allow confidentiality (on probation or parole)
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: NCT00218036
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218036
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
University of Texas
National Institute on Drug Abuse (NIDA)
Investigators
| 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
Additional Information:
| Responsible Party: | Joy Schmitz, Ph.D., University of Texas Medical School at Houston |
| ClinicalTrials.gov Identifier: | NCT00218036 History of Changes |
| Other Study ID Numbers: | NIDA-09262-8 P50DA009262-08 DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | December 11, 2009 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Cocaine Abuse Opiate Abuse |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Modafinil Armodafinil Citalopram Cocaine Dexetimide Methadone Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 26, 2016