Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

• 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 ]

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.

• Cocaine Abuse
• Opiate Dependence

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

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

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)