Clinical trial NCT05588726: Improving Insomnia in Patients With Opioid Use Disorder
Official title: Behavioral Intervention to Improve Insomnia Symptoms in Patients With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use Disorder
Insomnia
Keywords: Mindfulness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep Onset Latency
timeFrame: Day 28
Secondary outcomes:
measure: Non-Prescribed Opioid Use
timeFrame: Days -1, 7, 14, and 28
measure: Daytime Cravings
timeFrame: Days 1 through 14
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman School of Medicine, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nalaka Gooneratne, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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