Recruiting
Phase 3

Creatine

Sponsor:

Montana State University

Code:

NCT02568878

Conditions

Depression

Anxiety

Methamphetamine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Interventions

Creatine monohydrate

Study Details

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

Conditions

Depression

Anxiety

Methamphetamine Dependence

Study ID

NCT02568878

Start date

Nov, 2015

Status verified date

Dec, 2015

Completion date

May, 2017

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

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

Enrollment

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Creatine monohydrate

5 grams of daily creatine monohydrate by mouth for 8 weeks

Interventions

Creatine monohydrate

Primary outcome measure

  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Tracy Hellem, PhD

406 243 2110tracy.hellem1@montana.edu

Locations

Montana State University College of Nursing (Missoula campus)

Recruiting

Missoula, Montana, United States, 59812

Contacts

Tracy Hellem, PhD

406-243-2110tracy.Hellem1@montana.edu

4062432110

Principal Investigator:

Tracy Hellem, PhD

More Information

Sponsor

Montana State University

Last update posted

Dec 11, 2015

Last verified

Dec, 2015

Keywords

  • Depression
  • Anxiety
  • Methamphetamine dependence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montana State University on 2015-12-11.