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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA020479-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purposes of this study are:
Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trazodone | Active Comparator | 50-150mg (50mg capsules) at bedtime for 90 days |
|
| Placebo | Placebo Comparator | 1-3 capsules at bedtime for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone | Drug | 50 mg 1-3 capsules at bedtime for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality, as Measured by Total Sleep Time | Number of minutes spent sleeping during sleep period, as measured by daily sleep diary. | Baseline to 1-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Stein, MD | Rhode Island Hospital | Principal Investigator |
| Rogers Griffith, MD | The Miriam Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20155590 | Derived | Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155. |
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Participants were recruited from 8 methadone maintenance clinics in the Providence, RI area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trazodone | 50-150mg at bedtime |
| FG001 | Placebo | 1-3 capsules at bedtime |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trazodone | 50-150mg at bedtime |
| BG001 | Placebo | 1-3 at bedtime |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sleep Quality, as Measured by Total Sleep Time | Number of minutes spent sleeping during sleep period, as measured by daily sleep diary. | Intent to Treat | Posted | Mean | Standard Deviation | minutes | Baseline to 1-month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trazodone | 50-150mg at bedtime |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D. Stein, MD | Butler Hospital | 401-455-6646 | mstein@butler.org |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D014196 | Trazodone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011728 | Pyridones |
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| Placebo | Drug | 1-3 at bedtime |
|
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Placebo | 1-3 at bedtime | 0 | 68 | 0 | 68 |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011725 |
| Pyridines |
| D002241 | Carbohydrates |