Amphetamine-Type Substance Use DisorderNCT05799209
Floatation-REST in Methamphetamine Use Disorder: A Pilot Study
A study testing Float Pool and Float Chair in people with Amphetamine-Type Substance Use Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amphetamine-Type Substance Use Disorder
- What is being tested?
- Float Pool and Float Chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Sahib Khalsa, Md, PhD, 918-240-2583, skhalsa@laureateinstitute.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Amphetamine-Type Substance Use Disorder
- Being tested
- Float Pool, Float Chair
- Keywords
- Methamphetamine Use Disorder, Floatation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Float PoolDevice
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 ChairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Environmental Stimulation Pool | Experimental | floating supine in a pool for a prescribed amount of time (1 total session lasting 1 hour) Receives: Device: Float Pool |
| Zero Gravity Chair | Active comparator | floating supine in a zero-gravity chair for a prescribed amount of time (1 total session lasting 1 hour) Receives: Device: Float Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Over the span of the intervention, up to two weeks
Secondary outcomes (10)
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.
Measured: Over the ten days of intervention
Stimulant Craving on the Stimulant Craving Questionnaire (STCQ)-Brief
[Average change pre- to post-intervention]
Measured: 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
Measured: 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]
Measured: 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
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: Through completion of the final float session, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start15 Mar 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Type Substance Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants complete both arms of the study on separate days.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799209
- Sponsor's protocol ID
- 2022-001
- Status last verified
- Oct 2023
- First submitted
- 7 Mar 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Environmental Stimulation Therapy (REST) in Methamphetamine Use Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT05799209
- Acronym / sponsor ID
- 2022-001
- Conditions
- Amphetamine-Type Substance Use Disorder
- Keywords
- Methamphetamine Use Disorder, Floatation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants complete both arms of the study on separate days.
| Arm | Type | Receives |
|---|---|---|
| Reduced Environmental Stimulation Pool | Experimental | Device: Float Poolfloating supine in a pool for a prescribed amount of time (1 total session lasting 1 hour) |
| Zero Gravity Chair | Active comparator | Device: Float Chairfloating supine in a zero-gravity chair for a prescribed amount of time (1 total session lasting 1 hour) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Float PoolParticipant 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. | Device | Reduced Environmental Stimulation Pool |
| Float ChairParticipant 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. | Device | Zero Gravity Chair |
Primary outcome
Side Effects
Time frame: Over the span of the intervention, up to two weeks
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)
10 secondary outcomes
Completion Rate
Time frame: Over the ten days of intervention
Stimulant Craving on the Stimulant Craving Questionnaire (STCQ)-Brief
Time frame: Through completion of the final float session, up to two weeks
State Anxiety on the State Trait Anxiety Inventory (STAI)
Time frame: Through completion of the final float session, up to two weeks
Negative Affect on Positive and Negative Affective Schedule- X
Time frame: Through completion of the final float session, up to two weeks
Positive Affect on Positive and Negative Affective Schedule- X
Time frame: Through completion of the final float session, up to two weeks
Fear on Positive and Negative Affective Schedule- X
Time frame: Through completion of the final float session, up to two weeks
Fatigue on Positive and Negative Affective Schedule- X
Time frame: Through completion of the final float session, up to two weeks
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session, up to two weeks
Joviality on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session, up to two weeks
Attentiveness on the Positive and Negative Affect Schedule-X (PANAS-X)
Time frame: Through completion of the final float session, up to two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Float Pool and Float Chair in people with Amphetamine-Type Substance Use Disorder, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahib Khalsa, MD, PhD (918-240-2583, skhalsa@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Effects (time frame: Over the span of the intervention, up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.