Floatation-REST in Methamphetamine Use Disorder: A Pilot Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amphetamine-Type Substance Use Disorder
• Intervention / Treatment: Device: Float Pool; Device: Float Chair

Detailed Description

Methamphetamine Use Disorder (MUD) is associated with a barrage of mental and physical health problems including heightened drug craving/relapse/overdose rates, comorbid mood and anxiety disorders, and cardiovascular dysfunction. Unfortunately, MUD is becoming more prevalent. In the U.S., methamphetamine-related treatment admissions are increasing, as are methamphetamine-related deaths in recent years. Despite this substantial burden, there are currently no FDA approved pharmacological treatments for methamphetamine use disorder.

Recent models of addiction highlight the potential role that negative reinforcement plays in relapse, such that stress and negative affect increase drug craving, thereby increasing the likelihood of future drug seeking behaviors despite negative consequences. Consistent with this model, individuals may persist in methamphetamine use to avoid aversive states such as anxiety, depression, fatigue, and other withdrawal symptoms, a cycle known as negative reinforcement. Floatation-REST (Reduced Environmental Stimulation Therapy is a novel non-pharmacologic intervention that has been shown to reduce anxiety/stress in anxious and depressed individuals. It seems plausible that it may have the potential to lessen these aversive states in methamphetamine users, which may also relate to decreased state drug craving/urges to use. To our knowledge, no studies have tested the feasibility/tolerability and safety of floatation-REST in individuals with methamphetamine-type substance use disorder.

The current study investigates the safety and feasibility/tolerability of a single session of floatation-REST in treatment-seeking individuals with methamphetamine use disorder, relative to an active comparator. In this within-subject crossover design, participants will complete two counterbalanced sessions: one in a floatation pool (Pool-REST), and the other in a floatation chair (Chair-REST). Safety and tolerability will be assessed by self-report questionnaires as well as via pre- and post-session ratings of anxiety, stress, and drug craving. Feasibility will be assessed by intervention adherence rate. Findings from this study will inform the design of future feasibility and efficacy studies as well as mechanistic studies of recovery from methamphetamine addiction.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sahib Khalsa, Md, PhD; Phone Number: 918-240-2583; Email: skhalsa@laureateinstitute.org

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Laureate Institute for Brain Research
      • Contact: Sahib Khalsa, Md, PhD; Phone Number: 918-240-2583; Email: skhalsa@laureateinstitute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Environmental Stimulation Pool; floating supine in a pool for a prescribed amount of time (1 total session lasting 1 hour)	Device: 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.
Active Comparator: Zero Gravity Chair; floating supine in a zero-gravity chair for a prescribed amount of time (1 total session lasting 1 hour)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects	As a proxy of safety, the negative and positive side effects reported by each participant is equal to the number of instances during the study when a participant reports elevations above mild for any negative or positive effects on the side effect checklist (administered after each float session)	Over the span of the intervention, up to two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	As a proxy of feasibility, the rate of adherence for the group is equal to the total randomized minus (dropout plus withdrawn) divided by total randomized All participants are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.	Over the ten days of intervention
Stimulant Craving on the Stimulant Craving Questionnaire (STCQ)-Brief	[Average change pre- to post-intervention]	Through completion of the final float session, up to two weeks
State Anxiety on the State Trait Anxiety Inventory (STAI)	Average change pre to post-intervention	Through completion of the final float session, up to two weeks
Negative Affect on Positive and Negative Affective Schedule- X	Negative Affect subscale [Average change pre- to post-intervention]	Through completion of the final float session, up to two weeks
Positive Affect on Positive and Negative Affective Schedule- X	Positive Affect subscale [Average change pre to post-intervention	Through completion of the final float session, up to two weeks
Fear on Positive and Negative Affective Schedule- X	Fear subscale [Average change pre- to post-intervention]	Through completion of the final float session, up to two weeks
Fatigue on Positive and Negative Affective Schedule- X	Fatigue subscale [Average change pre- to post-intervention]	Through completion of the final float session, up to two weeks
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)	Serenity subscale [Average change pre to post-intervention]	Through completion of the final float session, up to two weeks
Joviality on the Positive and Negative Affect Schedule-X (PANAS-X)	Joviality subscale [Average change pre to post-intervention]	Through completion of the final float session, up to two weeks
Attentiveness on the Positive and Negative Affect Schedule-X (PANAS-X)	Attentiveness subscale [Average change pre to post-intervention]	Through completion of the final float session, up to two weeks

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Methamphetamine Use Disorder; Floatation Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2022-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes