Improving Insomnia in Patients With Opioid Use Disorder | NCT05588726

Studies
Improving Insomnia in Patients With Opioid Use Disorder

NCT05588726

Sponsor

University of Pennsylvania

Status

Withdrawn

Last Update Posted

May 25, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Opioid Use Disorder
Insomnia

Interventions

Sleep Hygiene
Mindfulness

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Staff no longer available to continue enrollment and other research activities

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

May 23, 2023Actual

Completion Date

May 23, 2023Actual

First Submitted Date

Oct 13, 2022

First Submission Date that Met QC Criteria

Oct 18, 2022

First Posted Date

Oct 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

This research study is exploring the effects of a simplified mindfulness intervention in patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. This study aims to improve their sleep quality, monitor changes in buprenorphine dose, and decrease the frequency of non-prescribed opioids use. We will be enrolling a total of 20 patients who are above 18 years of age and have insomnia symptoms, opioid use disorder, and access to a smartphone. Patients will be asked to utilize a smartphone application which will allow us to monitor adherence; they will be asked to tap on the screen in time with their breathing before bedtime. Buprenorphine maintenance therapy is used to treat opioid use disorder (the buprenorphine will be prescribed by their healthcare provider as part of their standard clinical care and is not a research study intervention) by minimizing withdrawal symptoms, but symptoms of insomnia often persist. Symptoms of insomnia include difficulty falling/staying asleep, anxiety regarding sleep, or daytime sleepiness.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep Hygiene	Active Comparator		Behavioral: Sleep Hygiene
Mindfulness	Experimental		Behavioral: Sleep Hygiene Behavioral: Mindfulness

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep Hygiene	Behavioral	Once weekly coaching calls with advice on sleep hygiene	Mindfulness Sleep Hygiene

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep Onset Latency	Time to fall asleep as derived from the Sleep Diary	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Non-Prescribed Opioid Use	Non-Prescribed Opioid Use Questionnaire	Days -1, 7, 14, and 28
Daytime Cravings	Smartphone app usage during the day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 18
Diagnosed with Opioid Use Disorder
Stable on Buprenorphine Maintenance Therapy for at least 4 weeks
At least 3 nights of greater than 30 minutes of sleep onset latency
Speak English above 6th grade level
Access to smart device

Exclusion Criteria:

Inability to communicate verbally
Involved in another insomnia study
Medical or other factors that in the opinion of the study research team would interfere with their ability to participate in the intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nalaka Gooneratne, MD, MSc	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Perelman School of Medicine, University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25988095	Background	Ardame A, Bassaknejad S, Zargard Y, Rokni P, Sayyah M. Examine the Relationship between Mindfulness and Drug Craving in Addicts Undergoing Methadone Maintenance Treatment. Iran J Public Health. 2014 Mar;43(3):349-54.
29933826	Background	Chakravorty S, Vandrey RG, He S, Stein MD. Sleep Management Among Patients with Substance Use Disorders. Med Clin North Am. 2018 Jul;102(4):733-743. doi: 10.1016/j.mcna.2018.02.012.

See Also Links

Label	URL
SAMHSA Results from 2018 National Survey on Drug Use and Health	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064866	Mindfulness

Ancestor Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This will be conducted as a parallel, single-blinded pilot study for reducing insomnia among patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. All subjects will participate in some form of insomnia treatment over a fourteen-day period (either the mindfulness relaxation therapy with sleep hygiene or only sleep hygiene for controls). Consent and screening will occur on Day -7, and the sleep diary will be assigned for baseline measurement. Randomization and survey baseline measurements from eligible participants will occur on Day -1, and participants will be randomized into one of two arms: one arm consisting of only the sleep hygiene intervention and the other consisting of both the sleep hygiene and mindfulness interventions. On Day 28, two weeks post-intervention(s), surveys will be emailed to participants to track any changes in sleep quality, mean buprenorphine dose, and frequency of non-prescribed opioid use.