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Improving Insomnia in Patients With Opioid Use Disorder

NCT05588726 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-25

No results posted yet for this study

Summary

This randomized, 35-day research study (n=20) explores the effects of a simplified mindfulness intervention in opioid use disorder patients stabilized on buprenorphine maintenance therapy (BMT), aiming to alleviate insomnia, monitor BMT dose, and decrease non-prescribed opioid use. Patients tap along with their breathing at bedtime and practice sleep hygiene; controls do sleep hygiene only. Adherence will be monitored by a smartphone application.

Conditions

Interventions

BEHAVIORAL

Sleep Hygiene

Once weekly coaching calls with advice on sleep hygiene

BEHAVIORAL

Mindfulness

Once weekly coaching calls with advice on mindfulness

Sponsors & Collaborators

Principal Investigators

  • Nalaka Gooneratne, MD, MSc · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-05-23
Completion
2023-05-23

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588726 on ClinicalTrials.gov