A Phase 4 interventional study of buprenorphine/naloxone in Opioid Use Disorder, sponsored by Friends Research Institute, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Friends Research Institute, Inc. · Phase 4, Interventional, and Treatment
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 40 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Friends Research Institute, Inc. is the lead sponsor of 44 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: buprenorphine/naloxone
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.
Drug: buprenorphine/naloxone
Participants will be dosed with buprenorphine/ naloxone strips
Also known as: suboxone
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
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
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Friends Research Institute, Inc.