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| Name | Class |
|---|---|
| MATClinics | UNKNOWN |
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This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.
This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week. Thereafter, they will be treated according to the MATClinics usual schedule of clinic visits. The number and timing of visits may vary according to whether the participant is still using illicit opioids. Follow-up visits for the study will be at one and three months.The primary objective is to determine whether patients randomly assigned to low versus high dose induction regimens are more likely to complete the 7-day induction period. Secondary outcomes are the number of patients who develop precipitated withdrawal or other adverse events, experience subjective opioid withdrawal symptoms, use adjunctive medications (hydroxyzine, loperamide, dicyclomine, clonidine, ibuprofen, methocarbamol, trazodone, ondansetron) provided by the clinic, recommendation of the medication induction scheme to other patients, and treatment retention at 1- and 3- months post induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose | Experimental | High dose: Participants randomized to the high dose group will receive on day 1 in the clinic an initial dose of 2 mg of buprenorphine/naloxone, followed by a 6 mg dose an hour later, followed by an 8 mg dose an hour later, followed by an 8 mg dose an hour later. On day 2 they will receive a 12 mg dose in the clinic and a 12 mg dose as take-home medication. On days 3 through 7 they will report to the clinic and receive their 12 mg morning dose and a 12 mg dose as a take-home for evening dosing. Thereafter, dosing adjustments can be made in the first three months of the trial. |
|
| low dose | Active Comparator | Low dose: Participants randomized to the low dose group will receive 0.5 mg of buprenorphine/naloxone on day 1, 0.5 mg bid on day 2, 1.0 mg bid on day 3, 2.0 mg bid on day 4, 4.0 mg bid on day 5, 4.0 mg tid on day 6, and 8 mg bid on day 7. Thereafter, dosing adjustments can be made in the first three months of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine/naloxone | Drug | Participants will be dosed with buprenorphine/ naloxone strips |
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| Measure | Description | Time Frame |
|---|---|---|
| pharmacotherapy adherence | completion of dose induction regimen (yes/no) | 1-7 days |
| pharmacotherapy adherence | number of days adherent to dose induction regiment | out of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Opiate Withdrawl Scale (COWS) | Precipitated withdrawal symptoms score; 11-item scale Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal | 1-7 days |
| Illicit opioid urine test results |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MATClinics | Dundalk | Maryland | 21222 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.
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Positive opioid urine drug screen
| baseline, 1-7 days, 1 month, 3month |
| Time Line Follow-Back (TLFB) Self-reported illicit opioid use | Self-report daily during first week then number of days during the past 30 for 1 and 3 month follow-ups | baseline, 1-7 days, 1 month, 3 month |
| Subjective Opiate Withdrawal Scale (SOWS) | Subjective opioid withdrawal symptoms score (1-10, mild withdrawal; 11-20 moderate withdrawal; 21-30 severe withdrawal) | 1-7 days |
| Adjunctive medications | Use of any adjunctive meds by self-report | 1-7 days |
| Concomitant medications checklist | Any medication taken by the participant to treat a medical or psychiatric disorder | 1-7 days, 1 month, 3 month |
| Adverse events (AEs) reporting form | Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses | baseline, 1-7 days, 1 month, 3 month |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |