Creatine for Depressed Male and Female Methamphetamine Users

Phase 3

Recruiting

• Conditions: Depression; Anxiety; Methamphetamine Dependence
• Interventions: Drug: Creatine monohydrate

• Registration Number: NCT02568878
• Lead Sponsor: Montana State University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Study Start: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11
• Primary Completion: 2016-10
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Creatine monohydrate	Creatine monohydrate	5 grams of daily creatine monohydrate by mouth for 8 weeks

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD) Scores	This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Hamilton Anxiety Rating Scale (HAMA) Scores	This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).

Secondary Outcome Measures

Name	Time	Method
Self-reported methamphetamine use	This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
Incidence of treatment-emergent adverse events	Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation).
Percent of positive urine drug screens for methamphetamine	This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).

Trial Locations

Locations (1)

Montana State University College of Nursing (Missoula campus); 🇺🇸 Missoula, Montana, United States