Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

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.

Study Overview

• Status: Terminated
• Conditions: Opiate Dependence; Cocaine Abuse
• Intervention / Treatment: Drug: Modafinil 200mg; Drug: Modafinil 400mg; Drug: Citalopram 20mg; Drug: Citalopram 40mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Retention	12 weeks of treatment
Medication Compliance	12 weeks of treatment

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Drug Abuse (NIDA); University of Texas
• Investigators: Principal Investigator: Joy M Schmitz, PhD, University of Texas; Study Chair: F. Gerard Moeller, M.D., University of Texas Medical School at Houston

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cocaine Abuse; Opiate Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Antiparkinson Agents; Anti-Dyskinesia Agents; Wakefulness-Promoting Agents; Citalopram; Dexetimide; Modafinil
• Other Study ID Numbers: NIDA-09262-8; DPMC (Other Identifier: NIDA); P50DA009262-08 (U.S. NIH Grant/Contract)