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Creatine for Depressed Male and Female Methamphetamine Users

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ClinicalTrials.gov Identifier: NCT02568878
Recruitment Status : Unknown
Verified December 2015 by Tracy Hellem, Montana State University.
Recruitment status was:  Recruiting
First Posted : October 6, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Tracy Hellem, Montana State University

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
Depression Anxiety Methamphetamine Dependence Drug: Creatine monohydrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
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 : November 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Creatine monohydrate
5 grams of daily creatine monohydrate by mouth for 8 weeks
Drug: Creatine monohydrate
Other Name: Creapure




Primary Outcome Measures :
  1. 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). ]
  2. 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 Measures :
  1. 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). ]
  2. 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). ]
  3. 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). ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568878


Contacts
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Contact: Tracy Hellem, PhD 406 243 2110 tracy.hellem1@montana.edu

Locations
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United States, Montana
Montana State University College of Nursing (Missoula campus) Recruiting
Missoula, Montana, United States, 59812
Contact: Tracy Hellem, PhD    406-243-2110    tracy.Hellem1@montana.edu   
Contact    4062432110      
Principal Investigator: Tracy Hellem, PhD         
Sponsors and Collaborators
Montana State University
Investigators
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Principal Investigator: Tracy Hellem, PhD Montana State University

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Responsible Party: Tracy Hellem, Assistant Professor, Montana State University
ClinicalTrials.gov Identifier: NCT02568878     History of Changes
Other Study ID Numbers: 01
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Tracy Hellem, Montana State University:
Depression
Anxiety
Methamphetamine dependence

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors