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Creatine for Depressed Male and Female Methamphetamine Users

Sponsor
Montana State University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02568878
Collaborator
(none)
29
Enrollment
1
Location
1
Arm
18
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Creatine monohydrate
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2016
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Creatine monohydrate

5 grams of daily creatine monohydrate by mouth for 8 weeks

Drug: Creatine monohydrate
Other Names:
  • Creapure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).]

    2. 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

    1. 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).]

    2. 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).]

    3. 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).]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montana State University College of Nursing (Missoula campus) Missoula Montana United States 59812

    Sponsors and Collaborators

    • Montana State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tracy Hellem, Assistant Professor, Montana State University
    ClinicalTrials.gov Identifier:
    NCT02568878
    Other Study ID Numbers:
    • 01
    First Posted:
    Oct 6, 2015
    Last Update Posted:
    Dec 11, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Tracy Hellem, Assistant Professor, Montana State University
    Depression
    Anxiety
    Methamphetamine dependence
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Dec 11, 2015