Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00218036
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), University of Texas (Other)
• Enrollment: 54
• Location: 1
• Arms: 5
• Duration (Months): 43.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Abuse; Opiate Dependence	Drug: Modafinil 200mg; Drug: Modafinil 400mg; Drug: Citalopram 20mg; Drug: Citalopram 40mg; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Confirmed Abstinence From Cocaine [12 weeks of treatment]

Secondary Outcome Measures

1. Retention [12 weeks of treatment]

2. Medication Compliance [12 weeks of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT00218036
• Other Study ID Numbers: NIDA-09262-8; P50DA009262-08; DPMC
• First Posted: Sep 22, 2005
• Last Update Posted: Nov 16, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston: Cocaine Abuse; Opiate Abuse
• Additional relevant MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders; Dexetimide; Modafinil; Citalopram

Study Results

Participant Flow

Pre-assignment Detail	54 were enrolled, but only 51 were randomized and started the study.

Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)	Modafinil 400mg/Methadone Maintenance (1.2mg/kg)	Citalopram 20mg/Methadone Maintenance (1.2mg/kg)	Citalopram 40mg/Methadone Maintenance (1.2mg/kg)	Placebo/Methadone Maintenance (1.2mg/kg)
Arm/Group Description	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.	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.	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.	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 while patient is methadone maintained on standard dose of 1.2 mg/kg
Period Title: Overall Study
STARTED	11	6	13	12	9
COMPLETED	6	3	5	6	3
NOT COMPLETED	5	3	8	6	6

Baseline Characteristics

Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)	Modafinil 400mg/Methadone Maintenance (1.2mg/kg)	Citalopram 20mg/Methadone Maintenance (1.2mg/kg)	Citalopram 40mg/Methadone Maintenance (1.2mg/kg)	Placebo/Methadone Maintenance (1.2mg/kg)	Total
Arm/Group Description	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.	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.	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.	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 while patient is methadone maintained on standard dose of 1.2 mg/kg	Total of all reporting groups
Overall Participants	11	6	13	12	9	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.364 (11.474)	40.333 (8.335)	38.769 (7.350)	36.500 (9.050)	36.556 (7.618)	37.510 (8.941)
Sex: Female, Male (Count of Participants)
Female	3 27.3%	1 16.7%	4 30.8%	4 33.3%	3 33.3%	15 29.4%
Male	8 72.7%	5 83.3%	9 69.2%	8 66.7%	6 66.7%	36 70.6%
Region of Enrollment (Count of Participants)
United States	11 100%	6 100%	13 100%	12 100%	9 100%	51 100%

Outcome Measures

1. Primary Outcome

Title	Confirmed Abstinence From Cocaine
Time Frame	12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.

Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)	Modafinil 400mg/Methadone Maintenance (1.2mg/kg)	Citalopram 20mg/Methadone Maintenance (1.2mg/kg)	Citalopram 40mg/Methadone Maintenance (1.2mg/kg)	Placebo/Methadone Maintenance (1.2mg/kg)
Arm/Group Description	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.	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.	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.	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 while patient is methadone maintained on standard dose of 1.2 mg/kg
Measure Participants	0	0	0	0	0

2. Secondary Outcome

Title	Retention
Time Frame	12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.

Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)	Modafinil 400mg/Methadone Maintenance (1.2mg/kg)	Citalopram 20mg/Methadone Maintenance (1.2mg/kg)	Citalopram 40mg/Methadone Maintenance (1.2mg/kg)	Placebo/Methadone Maintenance (1.2mg/kg)
Arm/Group Description	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.	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.	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.	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 while patient is methadone maintained on standard dose of 1.2 mg/kg
Measure Participants	0	0	0	0	0

3. Secondary Outcome

Title	Medication Compliance
Time Frame	12 weeks of treatment

Outcome Measure Data

Analysis Population Description

The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.

Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)	Modafinil 400mg/Methadone Maintenance (1.2mg/kg)	Citalopram 20mg/Methadone Maintenance (1.2mg/kg)	Citalopram 40mg/Methadone Maintenance (1.2mg/kg)	Placebo/Methadone Maintenance (1.2mg/kg)
Arm/Group Description	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.	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.	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.	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 while patient is methadone maintained on standard dose of 1.2 mg/kg
Measure Participants	0	0	0	0	0

Adverse Events

Adverse Event Reporting Description	The trial was terminated when the PI of the study left the institution. Collected data was stored in a database management system that has since become obsolete and is no longer accessible by current database programs.
Arm/Group Title	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)		Modafinil 400mg/Methadone Maintenance (1.2mg/kg)		Citalopram 20mg/Methadone Maintenance (1.2mg/kg)		Citalopram 40mg/Methadone Maintenance (1.2mg/kg)		Placebo/Methadone Maintenance (1.2mg/kg)
Arm/Group Description	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.		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.		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.		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 while patient is methadone maintained on standard dose of 1.2 mg/kg
All Cause Mortality
	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)		Modafinil 400mg/Methadone Maintenance (1.2mg/kg)		Citalopram 20mg/Methadone Maintenance (1.2mg/kg)		Citalopram 40mg/Methadone Maintenance (1.2mg/kg)		Placebo/Methadone Maintenance (1.2mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)		Modafinil 400mg/Methadone Maintenance (1.2mg/kg)		Citalopram 20mg/Methadone Maintenance (1.2mg/kg)		Citalopram 40mg/Methadone Maintenance (1.2mg/kg)		Placebo/Methadone Maintenance (1.2mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Modafinil 200mg/Methadone Maintenance (1.2mg/kg)		Modafinil 400mg/Methadone Maintenance (1.2mg/kg)		Citalopram 20mg/Methadone Maintenance (1.2mg/kg)		Citalopram 40mg/Methadone Maintenance (1.2mg/kg)		Placebo/Methadone Maintenance (1.2mg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Difficulty recruiting and lower than desired sample size.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.