Floatation-REST in Methamphetamine Use Disorder: A Pilot Study (NCT05799209) | Clinical Trial Compass
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Floatation-REST in Methamphetamine Use Disorder: A Pilot Study
United States100 participantsStarted 2022-03-15
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* …
What they're measuring
1
Side Effects
Timeframe: Over the span of the intervention, up to two weeks
Trial details
NCT IDNCT05799209
SponsorLaureate Institute for Brain Research, Inc.