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Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

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ClinicalTrials.gov Identifier: NCT00218036
Recruitment Status : Unknown
Verified December 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : December 15, 2009
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Cocaine Abuse Opiate Dependence Drug: Modafinil 200mg Drug: Modafinil 400mg Drug: Citalopram 20mg Drug: Citalopram 40mg Drug: Placebo Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
Study Start Date : July 2006
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Retention [ Time Frame: 12 weeks of treatment ]
  2. Medication Compliance [ Time Frame: 12 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More 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 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

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
Cocaine
Methadone
Opiate Alkaloids
Citalopram
Dexetimide
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
Analgesics, Opioid
Narcotics
Analgesics
Antitussive Agents
Respiratory System Agents