Floatation-REST in Methamphetamine Use Disorder: A Pilot Study

Status unconfirmed · Not applicable

Conditions studied: Amphetamine-Type Substance Use Disorder

In brief

This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 50 individuals receiving treatment for Amphetamine-Type Substance Use Disorder.

Key facts

Study ID

NCT05799209

Run by

Laureate Institute for Brain Research, Inc.

People needed

100

Starts

2022-03-15

Expected to finish

2024-08-01

Last updated by the study team

2023-10-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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