RECRUITING

Creatine for Depressed Male and Female Methamphetamine Users

Conditions

Depression Anxiety Methamphetamine Dependence

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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

* Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users * Assess creatine's effect on methamphetamine use * Assess the safety of creatine in male methamphetamine users with depression

Official Title

An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users

Quick Facts

Study Start:2015-11

Study Completion:2017-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02568878

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 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse * Current diagnosis of major depressive disorder (primary or substance-induced) * Current diagnosis of an anxiety disorder (primary or substance-induced) * Current Hamilton Depression Rating scale score \> or = to 16 * Current Hamilton Anxiety Scale score \> = to 18 * If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation	* Persons unable to provide adequate informed consent * Persons who are at clinically significant suicidal or homicidal risk * Primary substance-related diagnosis other than methamphetamine dependence or abuse * Positive pregnancy test (females only) * History of renal disease * Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing * History of hypersensitivity reaction to creatine

Inclusion Criteria

Exclusion Criteria

* Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse
* Current diagnosis of major depressive disorder (primary or substance-induced)
* Current diagnosis of an anxiety disorder (primary or substance-induced)
* Current Hamilton Depression Rating scale score \> or = to 16
* Current Hamilton Anxiety Scale score \> = to 18
* If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation

* Persons unable to provide adequate informed consent
* Persons who are at clinically significant suicidal or homicidal risk
* Primary substance-related diagnosis other than methamphetamine dependence or abuse
* Positive pregnancy test (females only)
* History of renal disease
* Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing
* History of hypersensitivity reaction to creatine

Contacts and Locations

Study Contact

Tracy Hellem, PhD

CONTACT

406 243 2110

tracy.hellem1@montana.edu

Principal Investigator

Tracy Hellem, PhD

PRINCIPAL_INVESTIGATOR

Montana State University

Study Locations (Sites)

Montana State University College of Nursing (Missoula campus)

Missoula, Montana, 59812

United States

Collaborators and Investigators

Sponsor: Montana State University

Tracy Hellem, PhD, PRINCIPAL_INVESTIGATOR, Montana State University

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 Date2015-11

Study Completion Date2017-05

Study Record Updates

Study Start Date2015-11

Study Completion Date2017-05

Terms related to this study

Keywords Provided by Researchers

Depression
Anxiety
Methamphetamine dependence

Additional Relevant MeSH Terms

Depression
Anxiety
Methamphetamine Dependence