Opiate AddictionPhase 2NCT03831113
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
A Phase 2 study testing Magnitude Group and Frequency Group in people with Opiate Addiction and Pregnancy, run by Steve N. Caritis, MD at 2 sites in United States.
Trial summary
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Opiate Addiction, Pregnancy
- What is being tested?
- Magnitude Group and Frequency Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2019to 22 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- On a stable dosing regimen of BUP for at least 2 weeks as part of an established medication- assisted treatment (MAT) program.
- Willingness to undergo supervised dose reduction
- Subject willingness to be assigned to either the Magnitude, or Frequency group.
- Single gestation between 14-30 weeks at the initiation of the dose reduction
- On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data points)
- Willingness to have urine samples tested for drugs of abuse and blood samples tested for BUP+M concentrations during the Medical Supervised Withdrawal (MSW) clinic appointments
- Willingness to attend weekly or biweekly MSW clinic appointments and to have daily contact via text messaging and to complete daily logs of sleep quality, withdrawal symptoms and symptoms of craving.
- Willingness to attend psychosocial support meetings as needed.
Who cannot join
- Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids other than BUP.
- Currently taking more than two mental health medications
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Current incarceration
- Lack of a phone or transportation to and from clinic
- Major fetal malformation
Show all 10Show fewer
- Mother with significant vaginal bleeding or serious medical or obstetrical complication that could adversely affect the study
- Planned delivery at another institution
- HIV or AIDS
- Diagnosis of schizoaffective disorder or psychosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
High Risk Obstetrical Consultants
Knoxville, Tennessee, 39720
Univerity of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.
Read the detailed description
Opioid use has reached a staggering level and the associated deaths, neonatal consequences and economic impact are devastating. Buprenorphine and methadone are the two most commonly used medications for pregnant women in a Medication Assisted Treatment (MAT) program. Yet, the target concentration of these agents is not clearly identified. Furthermore, the relationship between drug exposure and adverse effects such as Neonatal Abstinence Syndrome and neurodevelopmental outcomes is unclear but contemporary thinking is that exposure (defined by maternal dose) is unrelated to adverse outcomes. The benefit of an MAT strategy is based on strong clinical data that demonstrates an improvement in perinatal outcomes in women participating in an MAT program. However, some women prefer to stop opioid medications entirely , but are not afforded this option in many MAT programs. The possibility that MAT is associated with some harms has received little attention but there are data that suggest that opioids adversely affect the fetal brain. If MAT is indeed associated with potential harms, then the option of Medically Supervised Withdrawal could be considered.
This study will assess two dose reduction strategies in a cohort of women who desire a reduction or elimination of their opioid exposure. The magnitude group will reduce the dose by either 1 or 2 mg weekly. The frequency group will reduce their dose by 2 mg alternately in one or 2 weeks
- Conditions
- Opiate Addiction, Pregnancy
- Being tested
- Magnitude Group, Frequency Group
- Keywords
- Buprenorphine, medication-assisted treatment (MAT) programs
- Medical subject headings
- Opioid-Related Disorders, Short Stature, Auditory Canal Atresia, Mandibular Hypoplasia, Skeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnitude GroupDrug
Also called magnitude
Dose reductions will alternate between 1mg or 2 mg weekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
Frequency GroupDrug
Also called frequency
Dose reductions of 2 mg will occur alternate between once weekly to biweekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
| Study group | Role | What they receive |
|---|---|---|
| Magnitude Group | Active comparator | Subjects will receive alternating reductions of 1 mg or 2 mg weekly. Receives: Drug: Magnitude Group |
| Frequency Group | Active comparator | Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. Receives: Drug: Frequency Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Scores
The VAS questionnaire consists of 4 questions related to cravings (0 = not at all to 10 = very much), withdrawal (0 = no symptoms to 10 = symptoms all day), sleep quality (0 = best to 10 = worst), and sleep duration (0 = longest ever to 10 = shortest ever). The 4 component questions are summed to provide a single VAS score for that day. The daily scores are averaged over the week or for two weeks depending on how often the dose was changed. The average VAS scores for each reduction regimen are averaged and compared to the alternative dosing group.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start13 Apr 2019
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose reductions will alternate between 1 or 2 mg weekly (magnitude group) or 2 mg reductions every 1 or 2 weeks (frequency group)
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steve N. Caritis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Steve N. Caritis, MD, University of Pittsburgh
- Investigators
- Steve Caritis, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831113
- Sponsor's protocol ID
- STUDY19100128
- Other IDs
- R01HD096796
- Status last verified
- Aug 2024
- First submitted
- 22 Jan 2019
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
- ClinicalTrials.gov ID
- NCT03831113
- Acronym / sponsor ID
- STUDY19100128
- Conditions
- Opiate Addiction, Pregnancy
- Keywords
- Buprenorphine, medication-assisted treatment (MAT) programs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Steve N. Caritis, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.
Detailed description
Opioid use has reached a staggering level and the associated deaths, neonatal consequences and economic impact are devastating. Buprenorphine and methadone are the two most commonly used medications for pregnant women in a Medication Assisted Treatment (MAT) program. Yet, the target concentration of these agents is not clearly identified. Furthermore, the relationship between drug exposure and adverse effects such as Neonatal Abstinence Syndrome and neurodevelopmental outcomes is unclear but contemporary thinking is that exposure (defined by maternal dose) is unrelated to adverse outcomes. The benefit of an MAT strategy is based on strong clinical data that demonstrates an improvement in perinatal outcomes in women participating in an MAT program. However, some women prefer to stop opioid medications entirely , but are not afforded this option in many MAT programs. The possibility that MAT is associated with some harms has received little attention but there are data that suggest that opioids adversely affect the fetal brain. If MAT is indeed associated with potential harms, then the option of Medically Supervised Withdrawal could be considered.
This study will assess two dose reduction strategies in a cohort of women who desire a reduction or elimination of their opioid exposure. The magnitude group will reduce the dose by either 1 or 2 mg weekly. The frequency group will reduce their dose by 2 mg alternately in one or 2 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- dose reductions will alternate between 1 or 2 mg weekly (magnitude group) or 2 mg reductions every 1 or 2 weeks (frequency group)
| Arm | Type | Receives |
|---|---|---|
| Magnitude Group | Active comparator | Drug: Magnitude GroupSubjects will receive alternating reductions of 1 mg or 2 mg weekly. |
| Frequency Group | Active comparator | Drug: Frequency GroupSubjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- On a stable dosing regimen of BUP for at least 2 weeks as part of an established medication- assisted treatment (MAT) program.
- Willingness to undergo supervised dose reduction
- Subject willingness to be assigned to either the Magnitude, or Frequency group.
- Single gestation between 14-30 weeks at the initiation of the dose reduction
- On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data points)
Key exclusion criteria (10 listed)
- Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids other than BUP.
- Currently taking more than two mental health medications
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Current incarceration
- Lack of a phone or transportation to and from clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnitude GroupAlso: magnitudeDose reductions will alternate between 1mg or 2 mg weekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose. | Drug | Magnitude Group |
| Frequency GroupAlso: frequencyDose reductions of 2 mg will occur alternate between once weekly to biweekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose. | Drug | Frequency Group |
Primary outcome
Visual Analog Scale (VAS) Scores
Time frame: 36 weeks
The VAS questionnaire consists of 4 questions related to cravings (0 = not at all to 10 = very much), withdrawal (0 = no symptoms to 10 = symptoms all day), sleep quality (0 = best to 10 = worst), and sleep duration (0 = longest ever to 10 = shortest ever). The 4 component questions are summed to provide a single VAS score for that day. The daily scores are averaged over the week or for two weeks depending on how often the dose was changed. The average VAS scores for each reduction regimen are averaged and compared to the alternative dosing group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Caritis, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnitude Group and Frequency Group in people with Opiate Addiction and Pregnancy, run by Steve N. Caritis, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Scores (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.