Floatation therapy for methamphetamine use disorder

Reduced Environmental Stimulation Therapy (REST) in Methamphetamine Use Disorder: A Pilot Study

This study is testing if floatation therapy can help people recovering from methamphetamine use feel less anxious and stressed, which might lower their cravings for the drug.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Laureate Institute for Brain Research, Inc. (other)
• Locations: 1 site (Tulsa, Oklahoma)
• Trial ID: NCT05799209 on ClinicalTrials.gov

What this trial studies

This pilot trial investigates the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) in individuals with Methamphetamine Use Disorder. The study will involve 50 participants who have completed at least two weeks of inpatient treatment and are currently enrolled in ongoing treatment. The aim is to assess whether Floatation-REST can help reduce anxiety and stress, potentially decreasing drug cravings and the likelihood of relapse. Participants will engage in float pool and float chair sessions as part of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 who have a current diagnosis of methamphetamine use disorder and have completed at least two weeks of inpatient treatment.

Not a fit: Patients with severe mental health disorders such as schizophrenia or bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-pharmacological treatment option for individuals struggling with methamphetamine use disorder.

How similar studies have performed: While this specific approach is novel, previous studies have shown that floatation therapy can reduce anxiety and stress in other populations.

Eligibility criteria

Inclusion Criteria:

* Between 18-55 years of age
* Meeting criteria for a primary DSM-5 diagnosis of current methamphetamine use disorder
* Has completed at least two weeks of inpatient treatment (translating into having at least two weeks of drug/alcohol sobriety) at one of the two recruitment sites (Grand Addiction and Recovery Center or Women In Recovery) and is still currently enrolled in this treatment at the time of the study
* Capable of completing all measures during each session of the experiment: able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion Criteria:

* Has any of the following DSM-5 disorders: Schizophrenia Spectrum and Other Psychotic Disorders OR Bipolar I Disorder
* Participant fails to adhere to our "Pre-float checklist".
* Any antihistamine that causes drowsiness (e.g., Benadryl).
* Caffeine or nicotine consumed within the past 2 hours.
* Reports a history of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
* A breathalyzer test positive for alcohol or a drug-positive urine test at either session.
* Non-correctable vision or hearing problems.
* Unwillingness or inability to complete major aspects of the study protocol (e.g., floating). However, failing to complete some individual aspects will be acceptable (e.g., being unwilling to answer individual items on a questionnaire).

Where this trial is running

Tulsa, Oklahoma

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States (RECRUITING)

Study contacts

• Study coordinator: Sahib Khalsa, MD, PhD

Conditions: Amphetamine-Type Substance Use Disorder, Methamphetamine Use Disorder, Floatation Therapy