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Opioid Substitution Therapy
Buprenorphine Dosing Strategies for Opioid Use Disorder in Pregnancy
Phase 2
Recruiting
Led By Steve Caritis, MD
Research Sponsored by Steve N. Caritis, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Singleton gestation greater than 37 0/7 weeks
On a stable BID, TID or QID dosing regimen of BUP for at least 2 weeks as part of an established medication- assisted treatment (MAT) program.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
Study Summary
This trial will test how well different strategies for reducing the dose of BUP work for pregnant women.
Who is the study for?
This trial is for pregnant women in a Medication-Assisted Treatment (MAT) program, on stable doses of Buprenorphine or methadone, without recent use of certain drugs like cocaine or heroin. Participants must be willing to potentially experience mild withdrawal symptoms and attend regular clinic appointments.Check my eligibility
What is being tested?
The study tests different strategies for reducing Buprenorphine dosage during pregnancy. It will assess how well mothers tolerate reduced dosages by changing the amount (Magnitude Group), frequency (Frequency Group), or specific dosing approach (Dosing Group).See study design
What are the potential side effects?
Possible side effects may include mild, temporary withdrawal symptoms as the medication dose is reduced. These can involve feelings of discomfort, changes in mood, sleep quality issues, and cravings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 37 weeks pregnant with one baby.
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I have been on a stable dose of BUP for at least 2 weeks as part of my treatment program.
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I am taking a BUP dose of 6-24 mg daily.
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I haven't used cocaine, heroin, or certain other drugs in the last 8 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Opioid Withdrawal Scale (COWS) scores
Plasma levels of buprenorphine + metabolites, neurotransmitters (serotonin, dopamine and nor-adrenaline), and cotinine
Subjective Opioid Withdrawal Scale (SOWS) scores
+3 moreSecondary outcome measures
Urine toxicology screen
Trial Design
3Treatment groups
Experimental Treatment
Group I: Buprenorphine Magnitude GroupExperimental Treatment2 Interventions
Subjects will receive alternating reductions of 1 mg and then 2 mg weekly. Subjects on thrice daily (TID) or four times daily (QID) dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Group II: Buprenorphine Frequency GroupExperimental Treatment2 Interventions
Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. Subjects on TID or QID dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Group III: Buprenorphine Dosing GroupExperimental Treatment1 Intervention
Subjects will receive dose reductions identical to either the Magnitude (alternating 1 and 2 mg reductions) or Frequency (2 mg reductions on alternating 1 and 2 week intervals) groups. Subjects on BID dosing, as prescribed by their MAT provider, will be assigned to the Dosing group (n=10).
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Who is running the clinical trial?
Steve N. Caritis, MDLead Sponsor
2 Previous Clinical Trials
183 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,700 Total Patients Enrolled
Steve Caritis, MDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on BUP treatment for at least 12 weeks before giving birth and followed all clinic rules.I am experiencing complications in my current pregnancy such as high blood pressure, diabetes, or my baby is not growing as expected.I am taking more than two medications for my mental health.I am open to changing my medication schedule if needed.I have been on a stable dose of BUP for at least 2 weeks or am starting BUP therapy.The baby had a good Apgar score of 6 or higher at 5 minutes after birth.I am experiencing severe depression or have thoughts of suicide.I am over 37 weeks pregnant with one baby.I am willing to attend support meetings if needed.I have been diagnosed with schizoaffective disorder or psychosis.You are pregnant with only one baby and are between 35 and 38 weeks pregnant at the time of the fetal imaging.I have been on a stable dose of BUP for at least 2 weeks as part of my treatment program.I am taking more than one medication for my mental health.I am not currently using drugs like cocaine, heroin, or opioids other than BUP.I am taking a BUP dose of 6-24 mg daily.I am willing to have my medication dose reduced under supervision.I am willing to attend weekly or biweekly clinic visits, text daily, and keep daily logs of my sleep, withdrawal symptoms, and cravings.I can provide my prenatal care and BUP/methadone dosing records.I am living with HIV/AIDS.I don't have a phone or a way to get to the clinic.You have a significant birth defect.I haven't used cocaine, heroin, or certain other drugs in the last 8 weeks of pregnancy.I can provide prenatal records and BUP dosing information.You have consumed alcohol while pregnant.I have been on BUP for at least 8 weeks before giving birth.
Research Study Groups:
This trial has the following groups:- Group 1: Buprenorphine Dosing Group
- Group 2: Buprenorphine Frequency Group
- Group 3: Buprenorphine Magnitude Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is Buprenorphine: Dosing Group safe for persons?
"Despite the lack of clinical evidence supporting its efficacy, our team has assigned a score of 2 to Buprenorphine: Dosing Group due to existing data confirming its safety."
Answered by AI
How many participants are enrolled in this research study?
"Affirmative. Clinicaltrials.gov displays that this research endeavour, which was initially listed on April 13th 2019, is currently searching for participants. Specifically, 30 patients need to be recruited between 2 medical facilities."
Answered by AI
Are there still spots available to join this experiment?
"As reflected on clinicaltrials.gov, the trial is presently recruiting individuals to participate. This experiment was initially posted on April 13th 2019 and underwent a most recent update on June 8th 2022."
Answered by AI
Has research been conducted with regards to Buprenorphine: Dosing Group in the past?
"At the moment, 40 studies are ongoing for Buprenorphine: Dosing Group. 11 of them have advanced to Phase 3 trials and there is a total of 220 locations participating in these clinical investigations based largely in Durham, North carolina."
Answered by AI
Is the age range of participants in this medical study restricted to individuals above fifty years old?
"Those eligible to participate in this research must be between 18 and 45 years of age."
Answered by AI
Could I be a viable candidate to participate in this experiment?
"This investigation is looking to recruit 30 individuals with an opioid dependency aged 18-45. It's imperative that these potential participants meet the following conditions before being selected: stabilised dosing of buprenorphine (for no less than 2 weeks) through a maintenance program, or just beginning this regimen via MAT; plus, they must be willing to grant consent and endure moderate yet temporal withdrawal effects if already on BUP therapy."
Answered by AI
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