| September 16, 2005 |
| April 7, 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 ]
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| Cocaine craving and side effects |
| |
| 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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
- Cocaine Abuse
- Opiate Dependence
|
- Drug: Modafinil 200mg
- Drug: Modafinil 400mg
- Drug: Citalopram 20mg
- Drug: Citalopram 40mg
- Drug: Placebo
|
- Experimental: Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
- Experimental: Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
- Experimental: Citalopram 20/ Methadone Maintenance 1.2mg/kg
- Experimental: Citalopram 40/ Methadone Maintenance 1.2 mg/kg
- Placebo Comparator: Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
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| |
| |
| 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 |
|
|
| United States |
| |
| NCT00218036 |
| Joy Schmitz, Ph.D., University of Texas Medical School at Houston |
| NIDA-09262-8, P50-DA009262-8, DPMC |
| National Institute on Drug Abuse (NIDA) |
| University of Texas |
| 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) |
| April 2009 |