A Phase 2 interventional study of Magnitude Group and Frequency Group in Opiate Addiction and Pregnancy, sponsored by Steve N. Caritis, MD. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Steve N. Caritis, MD · Phase 2, Interventional, and Treatment
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.
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
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 13 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Steve N. Caritis, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive alternating reductions of 1 mg or 2 mg weekly.
Drug: Magnitude Group
Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks.
Drug: Frequency Group
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.
Also known as: magnitude
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.
Also known as: frequency
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.
Time frame: 36 weeks
Recruitment occurred in two Medication Assisted Treatment clinics either in Pittsburgh or in Knoxville.Recruitment started on 4/13/2019 and ended on 12/22/2022. All participants at the Tennessee site were assigned to the frequency group
| Milestone | Magnitude Group | Frequency Group |
|---|---|---|
| Started | 1 | 12 |
| Completed | 1 | 1 |
| Not completed | 0 | 11 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Protocol violation | 0 | 9 |
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.
| score on a scale | Magnitude Group | Frequency Group |
|---|---|---|
| 1 mg or 1 week cycle | 2.11 ± .12 | .43 ± .13 |
| 2 mg or 2 week cycle | 1.94 ± .23 | .43 ± .13 |
Collected over Participants were evaluated over the time from enrollment until delivery, generally 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnitude Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Frequency Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Magnitude Group | Frequency Group | Total |
|---|---|---|---|
| Mean | 26 ± 0 | 32.4 ± 6.1 | 31.8 ± 6.1 |
| Sex: Female, Male(Participants) | Magnitude Group | Frequency Group | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Magnitude Group | Frequency Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Magnitude Group | Frequency Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Steve N. Caritis, MD