Back to resultsCreatine for Depressed Male and Female Methamphetamine Users
Primary Purpose
Depression, Anxiety, Methamphetamine Dependence
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Creatine monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Anxiety, Methamphetamine dependence
Eligibility 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
Sites / Locations
- Montana State University College of Nursing (Missoula campus)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Creatine monohydrate
Arm Description
5 grams of daily creatine monohydrate by mouth for 8 weeks
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale (HAMD) Scores
Hamilton Anxiety Rating Scale (HAMA) Scores
Secondary Outcome Measures
Self-reported methamphetamine use
Incidence of treatment-emergent adverse events
Percent of positive urine drug screens for methamphetamine
Full Information
NCT ID
NCT02568878
First Posted
October 1, 2015
Last Updated
December 10, 2015
Sponsor
Montana State University
1. Study Identification
Unique Protocol Identification Number
NCT02568878
Brief Title
Creatine for Depressed Male and Female Methamphetamine Users
Official Title
An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Methamphetamine Dependence
Keywords
Depression, Anxiety, Methamphetamine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Creatine monohydrate
Arm Type
Experimental
Arm Description
5 grams of daily creatine monohydrate by mouth for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Creatine monohydrate
Other Intervention Name(s)
Creapure
Primary Outcome Measure Information:
Title
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).
Title
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).
Secondary Outcome Measure Information:
Title
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).
Title
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).
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Hellem, PhD
Phone
406 243 2110
Email
tracy.hellem1@montana.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Hellem, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montana State University College of Nursing (Missoula campus)
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Hellem, PhD
Phone
406-243-2110
Email
tracy.Hellem1@montana.edu
Phone
4062432110
First Name & Middle Initial & Last Name & Degree
Tracy Hellem, PhD
12. IPD Sharing Statement
Learn more about this trial
Creatine for Depressed Male and Female Methamphetamine Users
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