Creatine for Depressed Male and Female Methamphetamine Users

December 10, 2015 updated by: Tracy Hellem, Montana State University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Missoula, Montana, United States, 59812
        • Recruiting
        • Montana State University College of Nursing (Missoula campus)
        • Contact:
        • Contact:
          • Phone Number: 4062432110
        • Principal Investigator:
          • Tracy Hellem, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 55 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation).
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
Time Frame: 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).
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

This is where you will find people and organizations involved with this study.

Sponsor

Montana State University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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