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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants will be dosed with buprenorphine/ naloxone strips
MATClinics
Dundalk, Maryland, United States
pharmacotherapy adherence
completion of dose induction regimen (yes/no)
Time frame: 1-7 days
pharmacotherapy adherence
number of days adherent to dose induction regiment
Time frame: out of 7 days
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
Time frame: 1-7 days
Illicit opioid urine test results
Positive opioid urine drug screen
Time frame: 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
Time frame: 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)
Time frame: 1-7 days
Adjunctive medications
Use of any adjunctive meds by self-report
Time frame: 1-7 days
Concomitant medications checklist
Any medication taken by the participant to treat a medical or psychiatric disorder
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Time frame: 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
Time frame: baseline, 1-7 days, 1 month, 3 month