RECRUITING

Floatation-REST in Methamphetamine Use Disorder: A Pilot Study

Conditions

Amphetamine-Type Substance Use Disorder Methamphetamine Use Disorder Floatation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-15

Study Completion:2024-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05799209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Sahib Khalsa, MD, PhD

CONTACT

918-240-2583

skhalsa@laureateinstitute.org

Study Locations (Sites)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136

United States

Collaborators and Investigators

Sponsor: Laureate Institute for Brain Research, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-15

Study Completion Date2024-08-01

Study Record Updates

Study Start Date2022-03-15

Study Completion Date2024-08-01

Terms related to this study

Keywords Provided by Researchers

Methamphetamine Use Disorder
Floatation Therapy

Additional Relevant MeSH Terms

Amphetamine-Type Substance Use Disorder