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

September 16, 2005
December 11, 2009
July 2006
July 2010   (final data collection date for primary outcome measure)
Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
Substance use, retention and medication compliance
Complete list of historical versions of study NCT00218036 on ClinicalTrials.gov Archive Site
  • 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 ]
Cocaine craving and side effects
Not Provided
Not Provided
 
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cocaine Abuse
  • Opiate Dependence
  • 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.
  • 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.
  • 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.
  • 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.
  • Drug: Placebo
    Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
  • Experimental: 1
    Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
    Intervention: Drug: Modafinil 200mg
  • Experimental: 2
    Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
    Intervention: Drug: Modafinil 400mg
  • Experimental: 3
    Citalopram 20/ Methadone Maintenance 1.2mg/kg
    Intervention: Drug: Citalopram 20mg
  • Experimental: 4
    Citalopram 40/ Methadone Maintenance 1.2 mg/kg
    Intervention: Drug: Citalopram 40mg
  • Placebo Comparator: 5
    Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2011
July 2010   (final data collection date for primary outcome measure)

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)
Both
22 Years to 50 Years
Yes
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
 
NCT00218036
NIDA-09262-8, P50DA009262-08, DPMC
Yes
Joy Schmitz, Ph.D., University of Texas Medical School at Houston
University of Texas
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joy M Schmitz, PhD University of Texas
Study Chair: F. Gerard Moeller, M.D. University of Texas Medical School at Houston
National Institute on Drug Abuse (NIDA)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP