Improving Insomnia in Patients With Opioid Use Disorder (OUDInsomnia)

University of Pennsylvania

Status: Withdrawn

Conditions: Opioid Use Disorder; Insomnia

Treatments: Behavioral: Mindfulness; Behavioral: Sleep Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT05588726

844147

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Sleep Hygiene

Active Comparator group

Treatment:

Behavioral: Sleep Hygiene

Mindfulness

Experimental group

Treatment:

Behavioral: Mindfulness

Behavioral: Sleep Hygiene