Recruiting NCT02568878
Creatine for Depressed Male and Female Methamphetamine Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Creatine monohydrate.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety, Methamphetamine Dependence. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
Overview
* 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
Interventions
- Drug Creatine monohydrate
Primary outcome measures
- 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).]
Secondary outcome measures (3)
- 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).]
- 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).]
- 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).]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Montana State University College of Nursing (Missoula campus) — Missoula
Identifiers
NCT: NCT02568878 · 01