Recruiting

Floatation-REST

Sponsor:

Laureate Institute for Brain Research, Inc.

Code:

NCT05799209

Conditions

Amphetamine-Type Substance Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Float Pool

Float Chair

Study Details

Brief 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.

Conditions

Amphetamine-Type Substance Use Disorder

Study ID

NCT05799209

Start date

Mar 15, 2022

Status verified date

Oct, 2023

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reduced Environmental Stimulation Pool

floating supine in a pool for a prescribed amount of time (1 total session lasting 1 hour)

active comparator: Zero Gravity Chair

floating supine in a zero-gravity chair for a prescribed amount of time (1 total session lasting 1 hour)

Interventions

Float Pool

Participant floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Float Chair

Participant floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Primary outcome measure

  • Side Effects [ Time Frame: Over the span of the intervention, up to two weeks ]

Central Contacts and Locations

Central contacts

Sahib Khalsa, MD, PhD

918-240-2583skhalsa@laureateinstitute.org

Locations

Laureate Institute for Brain Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Sahib Khalsa, Md, PhD

918-240-2583skhalsa@laureateinstitute.org

More Information

Sponsor

Laureate Institute for Brain Research, Inc.

Last update posted

Oct 6, 2023

Last verified

Oct, 2023

Keywords

  • Methamphetamine Use Disorder
  • Floatation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laureate Institute for Brain Research, Inc. on 2023-10-06.