Creatine for Depressed Male and Female Methamphetamine Users

NCT ID: NCT02568878

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-05-31

Brief Summary

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* 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

Detailed Description

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Conditions

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Depression Anxiety Methamphetamine Dependence

Keywords

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Depression Anxiety Methamphetamine dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Creatine monohydrate

5 grams of daily creatine monohydrate by mouth for 8 weeks

Group Type EXPERIMENTAL

Creatine monohydrate

Intervention Type DRUG

Interventions

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Creatine monohydrate

Intervention Type DRUG

Other Intervention Names

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Creapure

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montana State University

OTHER

Sponsor Role lead

Responsible Party

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Tracy Hellem

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracy Hellem, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

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Montana State University College of Nursing (Missoula campus)

Missoula, Montana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tracy Hellem, PhD

Role: CONTACT

Phone: 406 243 2110

Email: [email protected]

Facility Contacts

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Tracy Hellem, PhD

Role: primary

Role: backup

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id