Trial Outcomes & Findings for Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

12 weeks of treatment

Results posted on

2018-11-16

Participant Flow

54 were enrolled, but only 51 were randomized and started the study.

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil 200mg/Methadone Maintenance (1.2mg/kg) n=11 Participants 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.	Modafinil 400mg/Methadone Maintenance (1.2mg/kg) n=6 Participants 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.	Citalopram 20mg/Methadone Maintenance (1.2mg/kg) n=13 Participants 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.	Citalopram 40mg/Methadone Maintenance (1.2mg/kg) n=12 Participants 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/Methadone Maintenance (1.2mg/kg) n=9 Participants Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg	Total n=51 Participants Total of all reporting groups
Age, Continuous	36.364 years STANDARD_DEVIATION 11.474 • n=5 Participants	40.333 years STANDARD_DEVIATION 8.335 • n=7 Participants	38.769 years STANDARD_DEVIATION 7.350 • n=5 Participants	36.500 years STANDARD_DEVIATION 9.050 • n=4 Participants	36.556 years STANDARD_DEVIATION 7.618 • n=21 Participants	37.510 years STANDARD_DEVIATION 8.941 • n=10 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	36 Participants n=10 Participants
Region of Enrollment United States	11 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	9 Participants n=21 Participants	51 Participants n=10 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks of treatment

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks of treatment

Population: 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.