Creatine for Depressed Male and Female Methamphetamine Users
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorMontana State University
About this trial
* 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Creatine monohydrate
Drug
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Creatine monohydrateExperimental treatment 1 intervention
Trial outcomes
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).Sponsors and contacts
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Source ClinicalTrials.gov