Creatine for Depressed Male and Female Methamphetamine Users

Depression Clinical Trial

Official title:

An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02568878
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 3
• First received: October 1, 2015
• Last updated: December 10, 2015
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: December 2015
• Source: Montana State University
• Contact: Tracy Hellem, PhD
• Phone: 406 243 2110
• Email: tracy.hellem1[@]montana.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: May 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Methamphetamine Dependence

Intervention

Drug:
• Creatine monohydrate

Locations

Country	Name	City	State
United States	Montana State University College of Nursing (Missoula campus)	Missoula	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Secondary	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).	No
Secondary	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).	Yes
Secondary	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).	No