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Mindfulness for Insomnia (OUDInsomnia Trial)

N/A

Waitlist Available

Led By Nalaka Gooneratne, MD, MSc

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days -1, 7, 14, and 28

Awards & highlights

OUDInsomnia Trial Summary

This trial studies how mindful breathing and sleep hygiene can help opioid-dependent patients on BMT reduce insomnia and non-prescribed opioid use. Adherence monitored with smartphone app.

Eligible Conditions

Insomnia
Opioid Use Disorder

OUDInsomnia Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days -1, 7, 14, and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days -1, 7, 14, and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days -1, 7, 14, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep Onset Latency

Secondary outcome measures

Daytime Cravings

Non-Prescribed Opioid Use

OUDInsomnia Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MindfulnessExperimental Treatment2 Interventions

Group II: Sleep HygieneActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Hygiene

2019

Completed Phase 2

~1030

Mindfulness

2014

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,088 Total Patients Enrolled

15 Trials studying Insomnia

4,616 Patients Enrolled for Insomnia

Nalaka Gooneratne, MD, MScPrincipal InvestigatorUniversity of Pennsylvania

2 Previous Clinical Trials

354 Total Patients Enrolled

1 Trials studying Insomnia

27 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently looking for additional subjects?

"Affirmative. Clinicaltrials.gov displays that this trial, which was initially posted on the first of January 2022 and recently updated on October 18th 2022, is actively seeking volunteers for participation. 20 individuals are needed from one clinical site."

Answered by AI

What is the enrollment threshold for this trial?

"Affirmative. Clinicaltrials.gov outlines that this medical study, first posted on the 1st of January 2022 and most recently updated on October 18th 2022, is actively recruiting participants. The trial requires 20 patients to be enrolled at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Insomnia in Patients With Opioid Use Disorder

2022. "Improving Insomnia in Patients With Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588726.