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TerminatedNCT04468360

Pharmacokinetic Study for IV Allopregnanolone

This study has public registry information. It focuses on PTSD and currently lists study information in the United States.

PTSD, Pharmacokinetic StudyDrugFrom 18 Years to 55 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis may be useful for adults experiencing ptsd.

What would participation involve?

Participants may receive PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with ptsd.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: March 4, 2022
Recruitment status
Terminated
Estimated enrollment
11
Sponsor
Boston University
Sponsor type
University
Study type
Drug
Intervention type
Medication / drug
Study phase
PHASE2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States
Age range
From 18 Years to 55 Years
Official registry ID
NCT04468360
Official title
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD- Pharmacokinetic Studies
Official source
Official registry link

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Study ID: NCT04468360. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences,. The study team can confirm the exact objective and what it means for you.

Does this study involve a medication?

This appears to be a medication / drug study involving PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis, PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.. The listed phase is PHASE2. Ask the study team what that means in practice for safety, monitoring, and criteria.

Who might this study be for?

This study may concern people with ptsd; age range: From 18 Years to 55 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Boston University, which appears to be a university. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is not currently recruiting. Check the official registry for the reason and latest status. The registry lists an estimated enrollment of 11 participants.

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