Anxiety, Depression, Methamphetamine Dependence
Conditions
Keywords
Depression, Anxiety, Methamphetamine dependence
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
Interventions
DRUGCreatine monohydrate
Sponsors
Montana State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactTracy Hellem, PhD
Outcome results
None listed