Conditions: Cocaine Abuse Opiate Dependence
Keywords: Cocaine Abuse Opiate Abuse
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: yes

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.

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.

Arms:
arm 1: Modafinil 200mg / Methadone Maintenance (1.2mg/kg) arm 2: Modafinil 400mg/ Methadone Maintenance (1.2mg/kg) arm 3: Citalopram 20/ Methadone Maintenance 1.2mg/kg arm 4: Citalopram 40/ Methadone Maintenance 1.2 mg/kg arm 5: Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study

Interventions: intervention 1: Modafinil 200mg intervention 2: Modafinil 400mg intervention 3: Citalopram 20mg intervention 4: Citalopram 40mg intervention 5: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Protocol document: