Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

Conditions
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Cocaine Abuse, Opiate Dependence

Intervention / Treatment
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* Drug: Modafinil 200mg
* Drug: Modafinil 400mg
* Drug: Citalopram 20mg
* Drug: Citalopram 40mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Modafinil 200mg / Methadone Maintenance (1.2mg/kg) | Drug: Modafinil 200mg<br>* 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.<br>|
| Experimental: 2<br>Modafinil 400mg/ Methadone Maintenance (1.2mg/kg) | Drug: Modafinil 400mg<br>* 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.<br>|
| Experimental: 3<br>Citalopram 20/ Methadone Maintenance 1.2mg/kg | Drug: Citalopram 20mg<br>* 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.<br>|
| Experimental: 4<br>Citalopram 40/ Methadone Maintenance 1.2 mg/kg | Drug: Citalopram 40mg<br>* 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.<br>|
| Placebo Comparator: 5<br>Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study | Drug: Placebo<br>* Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Abstinence From Cocaine |  | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention |  | 12 weeks of treatment | 
| Medication Compliance |  | 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine Abuse, Opiate Abuse