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Creatine for Depressed Male and Female Methamphetamine Users

An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 59 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether creatine helps depression and anxiety and changes methamphetamine use in men and women who use methamphetamine. It also checks the safety of creatine in men who use methamphetamine and have depression.

* 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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a current diagnosis of methamphetamine addiction or harmful use, with methamphetamine as your main drug of use.
  • Have major depression, whether or not it is caused by drug use.
  • Have an anxiety disorder, whether or not it is caused by drug use.
  • Score at least 16 on the Hamilton Depression Rating Scale, which measures depression symptoms.
  • Score at least 18 on the Hamilton Anxiety Scale, which measures anxiety symptoms.
  • If you take medicine for depression or anxiety, have no changes to it for at least 4 weeks before starting creatine.

Who can't join

  • Cannot understand the study well enough to agree to take part.
  • Have a serious risk of suicide or killing someone else.
  • Have a main drug-use diagnosis other than methamphetamine addiction or harmful use.
  • Have a positive pregnancy test.
  • Have a history of kidney disease.
  • Have a serious medical illness or a serious illness of the brain or nerves found through your health history, exam, or lab tests.
  • Have had an allergic reaction to creatine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MT