- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02568878
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 Contact
- Name: Tracy Hellem, PhD
- Phone Number: 406 243 2110
- Email: tracy.hellem1@montana.edu
Study Locations
-
-
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
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
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
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
|
Other Names:
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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
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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