Using creatine to help treat depression in methamphetamine users
An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
This study is testing if creatine can help reduce depression and anxiety in people who are dependent on methamphetamine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Montana State University Academic / other |
| Locations | 1 site (Missoula, Montana) |
| Trial ID | NCT02568878 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of creatine monohydrate on depression and anxiety in male and female individuals who are dependent on methamphetamine. It aims to determine whether creatine can alleviate depressive symptoms and reduce methamphetamine use while also assessing its safety in this population. Participants must have a current diagnosis of methamphetamine dependence, major depressive disorder, and an anxiety disorder, with specific severity scores on standardized scales. The study will monitor the participants' responses to creatine over a defined treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults with a primary diagnosis of methamphetamine dependence, major depressive disorder, and an anxiety disorder.
Not a fit: Patients with primary substance-related diagnoses other than methamphetamine dependence or those with significant medical or neurological illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for individuals struggling with depression and methamphetamine dependence.
How similar studies have performed: While the use of creatine for depression is an emerging area of interest, this specific application in methamphetamine users is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Missoula, Montana
- Montana State University College of Nursing (Missoula campus) — Missoula, Montana, United States (Recruiting)
Study contacts
- Principal investigator: Tracy Hellem, PhD — Montana State University
- Study coordinator: Tracy Hellem, PhD
- Email: tracy.hellem1@montana.edu
- Phone: 406 243 2110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.