MATClinics
Dundalk, Maryland, 21222, United States
NCT Number: NCT05944952
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 is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 4
Dundalk, Maryland, 21222, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be dosed with buprenorphine/ naloxone strips
Other names: suboxone
Time frame: 1-7 days
completion of dose induction regimen (yes/no)
Time frame: out of 7 days
number of days adherent to dose induction regiment
Time frame: 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
Time frame: baseline, 1-7 days, 1 month, 3month
Positive opioid urine drug screen
Time frame: 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
Time frame: 1-7 days
Subjective opioid withdrawal symptoms score (1-10, mild withdrawal; 11-20 moderate withdrawal; 21-30 severe withdrawal)
Time frame: 1-7 days
Use of any adjunctive meds by self-report
Time frame: 1-7 days, 1 month, 3 month
Any medication taken by the participant to treat a medical or psychiatric disorder
Time frame: baseline, 1-7 days, 1 month, 3 month
Any reaction, side effect, or untoward event that occurs during the clinical trial, including reported overdoses
Friends Research Institute, Inc.
Other
A Pilot Study Comparing a Low-dose Versus a High-dose Sublingual Buprenorphine Induction Dosing Scheme in Fentanyl Using Patients With Opioid Use Disorder (OUD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06089707
Chemically-Induced Disorders, Mental Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT05897788
Chemically-Induced Disorders, Mental Disorders
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06441604
Chemically-Induced Disorders, Mental Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT06540105
Addiction, Opioid, Chemically-Induced Disorders
La Jolla, California, United States
View Trial Details