Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8



Status:Terminated
Conditions:Psychiatric, Gastrointestinal, Pulmonary
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - 50
Updated:11/18/2018
Start Date:July 2006
End Date:February 2010

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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.

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)
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