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
Sponsor:
Collaborator:
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
  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:


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
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

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
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

No publications provided

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:
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Citalopram
Dexetimide
Cocaine
Modafinil
Armodafinil
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 21, 2014