NCT03831113

Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

Terminated Phase 2 Results posted Last updated 29 August 2024

What this trial tests

Phase 2 trial testing Magnitude Group in Opiate Addiction in 13 participants. Terminated before completion.

Timeline

13 April 2019

Primary endpoint
22 December 2022

22 December 2022

Quick facts

Lead sponsor	Steve N. Caritis, MD
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	13 April 2019
Primary completion	22 December 2022
Estimated completion	22 December 2022
Sites	2 locations across United States

Drugs / interventions tested

• Magnitude Group — full drug profile →
• Frequency Group — full drug profile →

Conditions studied

• Opiate Addiction — all drugs for Opiate Addiction →
• Pregnancy — all drugs for Pregnancy →

Sponsor

Steve N. Caritis, MD — full company profile →

Who can join

Adults 18 to 45, female only, with Opiate Addiction or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Analog Scale (VAS) Scores Primary · 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.

1 mg or 1 week cycle

Group	Value	95% CI
Magnitude Group	2.11	± .12
Frequency Group	.43	± .13

2 mg or 2 week cycle

Group	Value	95% CI
Magnitude Group	1.94	± .23
Frequency Group	.43	± .13

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.