Clinical trial NCT02568878: Creatine for Depressed Male and Female Methamphetamine Users
Official title: An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Depression
Anxiety
Methamphetamine Dependence
Keywords: Depression
Anxiety
Methamphetamine dependence
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAMD) Scores
timeFrame: 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).
measure: Hamilton Anxiety Rating Scale (HAMA) Scores
timeFrame: 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:
measure: Self-reported methamphetamine use
timeFrame: 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).
measure: Incidence of treatment-emergent adverse events
timeFrame: Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation).
measure: Percent of positive urine drug screens for methamphetamine
timeFrame: 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).
Other outcomes:
Locations:
city: Missoula
country: United States
facility: Montana State University College of Nursing (Missoula campus)
state: Montana
Study officials:
affiliation: Montana State University
name: Tracy Hellem, PhD
role: PRINCIPAL_INVESTIGATOR
References: