Creatine for Depressed Male and Female Methamphetamine Users

Montana State University

Status and phase: Enrolling; Phase 3

Conditions: Methamphetamine Dependence; Depression; Anxiety

Treatments: Drug: Creatine monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02568878

01

Details and patient eligibility

About

• 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

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Creatine monohydrate

Experimental group

Description:

5 grams of daily creatine monohydrate by mouth for 8 weeks

Treatment:

Drug: Creatine monohydrate