Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02568878

Creatine for Depressed Male and Female Methamphetamine Users

* 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Methamphetamine Dependence

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montana State University College of Nursing (Missoula campus)

Missoula, Montana, 59812, United States

Location status: Recruiting

Location contact

Tracy Hellem, PhD

CONTACT

[email protected]

406-243-2110

Tracy Hellem, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

4062432110

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine monohydrate

Drug

Other names: Creapure

Primary outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy Hellem, PhD

CONTACT

[email protected]

406 243 2110

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.