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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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.
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
RECRUITINGSide 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)
Time frame: Over the span of the intervention, up to two weeks
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.
Time frame: Over the ten days of intervention
Stimulant Craving on the Stimulant Craving Questionnaire (STCQ)-Brief
\[Average change pre- to post-intervention\]
Time frame: 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
Time frame: Through completion of the final float session, up to two weeks
Negative Affect on Positive and Negative Affective Schedule- X
Negative Affect subscale \[Average change pre- to post-intervention\]
Time frame: 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
Time frame: Through completion of the final float session, up to two weeks
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Fear on Positive and Negative Affective Schedule- X
Fear subscale \[Average change pre- to post-intervention\]
Time frame: Through completion of the final float session, up to two weeks
Fatigue on Positive and Negative Affective Schedule- X
Fatigue subscale \[Average change pre- to post-intervention\]
Time frame: Through completion of the final float session, up to two weeks
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
Serenity subscale \[Average change pre to post-intervention\]
Time frame: Through completion of the final float session, up to two weeks
Joviality on the Positive and Negative Affect Schedule-X (PANAS-X)
Joviality subscale \[Average change pre to post-intervention\]
Time frame: Through completion of the final float session, up to two weeks
Attentiveness on the Positive and Negative Affect Schedule-X (PANAS-X)
Attentiveness subscale \[Average change pre to post-intervention\]
Time frame: Through completion of the final float session, up to two weeks