Creatine for Depressed Male and Female Methamphetamine Users
Purpose
- 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
Conditions
- Depression
- Anxiety
- Methamphetamine Dependence
Eligibility
- Eligible Ages
- Between 18 Years and 59 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Creatine monohydrate |
5 grams of daily creatine monohydrate by mouth for 8 weeks |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Montana State University
