Opioid Use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGbuprenorphine/naloxone
Participants will be dosed with buprenorphine/ naloxone strips
Sponsors
MATClinics
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult male or female (≥ 18 years of age) persons with a DSM-5 diagnosis of OUD; * Must have a fentanyl positive urine test; * Able to come to the clinic every day for the first week of treatment.
Exclusion criteria
* No exclusionary medical history or mental health issues as determined by the admitting provider; e.g., patients with untreated or unstable serious mental illness, including psychotic disorders; * Alcohol withdrawal requiring pharmacological management; * Urine positive for buprenorphine, benzodiazepines, or methadone; 4. Enrolled in a methadone treatment program in the past 14 days; 5. Inability to pass a study enrollment quiz.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacotherapy adherence | 1-7 days | completion of dose induction regimen (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Illicit opioid urine test results | baseline, 1-7 days, 1 month, 3month | Positive opioid urine drug screen |
| Time Line Follow-Back (TLFB) Self-reported illicit opioid use | baseline, 1-7 days, 1 month, 3 month | Self-report daily during first week then number of days during the past 30 for 1 and 3 month follow-ups |
| Subjective Opiate Withdrawal Scale (SOWS) | 1-7 days | Subjective opioid withdrawal symptoms score (1-10, mild withdrawal; 11-20 moderate withdrawal; 21-30 severe withdrawal) |
| Clinical Opiate Withdrawl Scale (COWS) | 1-7 days | Precipitated withdrawal symptoms score; 11-item scale Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal |
| Concomitant medications checklist | 1-7 days, 1 month, 3 month | Any medication taken by the participant to treat a medical or psychiatric disorder |
| Adverse events (AEs) reporting form | baseline, 1-7 days, 1 month, 3 month | Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses |
| Adjunctive medications | 1-7 days | Use of any adjunctive meds by self-report |
Countries
United States
Outcome results
None listed