Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Opiate Dependence Clinical Trial

Official title:

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00218036
• Other study ID #: NIDA-09262-8
• Secondary ID: P50DA009262-08DP
• Status: Terminated
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: February 2010

Study information

• Verified date: October 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine-Related Disorders
• Opiate Dependence
• Opioid-Related Disorders

Intervention

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.
• 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.
• 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.
• 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
Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA), University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Abstinence From Cocaine		12 weeks of treatment
Secondary	Retention		12 weeks of treatment
Secondary	Medication Compliance		12 weeks of treatment