Effects of a sleep medication on cravings and stress in stimulant use disorder
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study
This study is testing whether a sleep medication can help people in early recovery from stimulant use feel less stressed and have fewer cravings while they are in a treatment program.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06444256 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of suvorexant, a medication that targets orexin receptors, on sleep quality, stress levels, and drug cravings in individuals undergoing early abstinence from stimulant use disorder. Participants will be compared between those receiving suvorexant and those receiving standard treatment. The study aims to assess how this intervention affects the length of stay and completion rates in a residential treatment program over a 30-day period following treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with stimulant use disorder, specifically those using cocaine or methamphetamine, who are fluent in English.
Not a fit: Patients with opioid use disorder, severe comorbid substance use disorders, or certain medical conditions that contraindicate the use of suvorexant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sleep and reduce cravings in patients recovering from stimulant use disorder, potentially enhancing treatment outcomes.
How similar studies have performed: While the specific approach of using suvorexant in this context may be novel, other studies have explored the relationship between sleep and substance use disorders, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine) * Be fluent in English and able to understand the consent form Exclusion Criteria: * Have an opioid use disorder of any severity * Have a greater than moderate substance use disorder on any other substance * Undergoing medication-assisted treatment for withdrawal of any substance * Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy) * Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative) * Are pregnant or breast feeding * BMI \> 30 (women only) * Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe * Have history of seizure disorder * Have a head injury with loss of consciousness in the last 5 years
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Heather Webber, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Heather Webber, PhD
- Email: Heather.E.Webber@uth.tmc.edu
- Phone: 713-486-2723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.