Creatine for Depressed Male and Female Methamphetamine Users

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

• 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

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety; Methamphetamine Dependence
• Intervention / Treatment: Drug: Creatine monohydrate

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tracy Hellem, PhD; Phone Number: 406 243 2110; Email: tracy.hellem1@montana.edu

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59812
      • Recruiting
      • Montana State University College of Nursing (Missoula campus)
      • Contact: Tracy Hellem, PhD; Phone Number: 406-243-2110; Email: tracy.hellem1@montana.edu
      • Contact: Phone Number: 4062432110
      • Principal Investigator: Tracy Hellem, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine monohydrate; 5 grams of daily creatine monohydrate by mouth for 8 weeks	Drug: Creatine monohydrate; Other Names: Creapure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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).

Collaborators and Investigators

• Sponsor: Montana State University
• Investigators: Principal Investigator: Tracy Hellem, PhD, Montana State University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Methamphetamine dependence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 01 (Miami VAHS)