Creatine for Depressed Male and Female Methamphetamine Users

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montana State University
• Treatments: Methamphetamine

Criteria

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