The effect of baclofen vs placebo on the activation of the mesolimbic dopaminergic system in methamphetamine dependent subjects: fMRI study.

inear Clinical Research Ltd0 sites18 target enrollmentNovember 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

inear Clinical Research Ltd

•1\.Methamphetamine Dependent individuals (DSM criteria).
•2\.Aged 18 \- 40 years.
•3\.Using methamphetamine intravenously or by smoking.
•4\.Using methamphetamine at least 8 out of previous 30 days prior to the screening interview.
•5\.Available and willing to undertake a 7 day inpatient detoxification in a closed clinical trial unit.
•6\.Able to undergo fMRI – no claustrophobia, no implanted metal etc.
•7\.Competent and willing to consent via written informed consent to participate in the trial including drug testing, screening tests and follow up.

•1\.Taking oral dopaminergic medication in the last 8 weeks – especially antipsychotic medications.
•2\.Any use of depot antipsychotic medication.
•3\.History of psychosis, seizures or organic brain syndrome.
•4\.Physically dependent on alcohol, cannabis or benzodiazepines (DSM Criteria).
•5\.Clinically significant medical conditions that, in the opinion of the investigator, may adversely impact on the participant’s ability to complete the study, including, but not limited to \- Cardiovascular, Haematological, Hepatic, Renal, Neurological, Endocrine.
•6\.Known HIV infection or has a positive test for human immunodeficiency virus (HIV) at the screening visit.
•7\.History of brain trauma.
•8\.History of violent behaviour, antisocial or borderline personality disorder.
•9\.Homeless.
•10\.Any other condition which, in the opinion of the Investigator, makes the volunteer unsuitable for the study.