Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009262-08 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
Not provided
Not provided
Not provided
PI left institution, end of funding, clinic relocation, recruitment issues
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Texas | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Modafinil 200mg / Methadone Maintenance (1.2mg/kg) |
|
| 2 | Experimental | Modafinil 400mg/ Methadone Maintenance (1.2mg/kg) |
|
| 3 | Experimental | Citalopram 20/ Methadone Maintenance 1.2mg/kg |
|
| 4 | Experimental | Citalopram 40/ Methadone Maintenance 1.2 mg/kg |
|
| 5 | Placebo Comparator | Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil 200mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Abstinence From Cocaine | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | 12 weeks of treatment | |
| Medication Compliance | 12 weeks of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joy M Schmitz, PhD | University of Texas | Principal Investigator |
| F. Gerard Moeller, M.D. | University of Texas Medical School at Houston | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
54 were enrolled, but only 51 were randomized and started the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Placebo/Methadone Maintenance (1.2mg/kg) | Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Modafinil 400mg/Methadone Maintenance (1.2mg/kg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Abstinence From Cocaine | 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. | Posted | 12 weeks of treatment |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Difficulty recruiting and lower than desired sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy M Schmitz, PhD | The University of Texas Health Science Center at Houston | (713) 486-2867 | Joy.M.Schmitz@uth.tmc.edu |
Not provided
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Modafinil 400mg | Drug | 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 | Drug | 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 | Drug | 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 | Drug | Placebo while patient is methadone maintained on standard dose of 1.2 mg/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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Placebo/Methadone Maintenance (1.2mg/kg) | Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Placebo/Methadone Maintenance (1.2mg/kg) | Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg |
|
| Secondary | Retention | 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. | Posted | 12 weeks of treatment |
|
|
| Secondary | Medication Compliance | 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. | Posted | 12 weeks of treatment |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Placebo/Methadone Maintenance (1.2mg/kg) | Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |