Creatine for Depressed Male and Female Methamphetamine Users

NCT02568878 | Recruiting Phase 3

• 1 other identifier: 01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; Anxiety; Methamphetamine dependence

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (1)

Creatine monohydrate

EXPERIMENTAL

5 grams of daily creatine monohydrate by mouth for 8 weeks

Drug: Creatine monohydrate

Interventions

Creatine monohydrate DRUG

Also known as: Creapure

Creatine monohydrate

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Montana State University College of Nursing (Missoula campus)

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Creatine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Tracy Hellem, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Hellem, PhD

CONTACT

406 243 2110; tracy.hellem1@montana.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 6, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

US (1)