Cocaine Abuse, Opiate Dependence
Conditions
Keywords
Cocaine Abuse, Opiate Abuse
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.
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.
Interventions
DRUGModafinil 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.
DRUGModafinil 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.
DRUGCitalopram 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.
DRUGCitalopram 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.
DRUGPlacebo
Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
Sponsors
National Institute on Drug Abuse (NIDA)
University of Texas
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed Abstinence From Cocaine | 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Retention | 12 weeks of treatment |
| Medication Compliance | 12 weeks of treatment |
Countries
United States
Participant flow
Pre-assignment details
54 were enrolled, but only 51 were randomized and started the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 6 |
| 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. | 13 |
| 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. | 12 |
| Placebo/Methadone Maintenance (1.2mg/kg) Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg | 9 |
| Total | 51 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.364 years STANDARD_DEVIATION 11.474 | 40.333 years STANDARD_DEVIATION 8.335 | 38.769 years STANDARD_DEVIATION 7.35 | 36.500 years STANDARD_DEVIATION 9.05 | 36.556 years STANDARD_DEVIATION 7.618 | 37.510 years STANDARD_DEVIATION 8.941 |
| Region of Enrollment United States | 11 Participants | 6 Participants | 13 Participants | 12 Participants | 9 Participants | 51 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants | 4 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 9 Participants | 8 Participants | 6 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Confirmed Abstinence From Cocaine
Time frame: 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.
Secondary
Medication Compliance
Time frame: 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.
Secondary
Retention
Time frame: 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.