Baclofen Trial

Inclusion Criteria:

1.     Methamphetamine      Dependent     individuals     (DSM-5     criteria/ Appendix A).

2.     Aged 18 – 50 years inclusive.

3.     Using methamphetamine intravenously or by smoking.

4.     Using methamphetamine at least 8 out of previous 30days prior to the screening interview.

5.     Available and willing to undertake a 7 day inpatientdetoxification in a closed clinical trial unit.

6.     Able to undergo fMRI – no claustrophobia, noimplanted metal etc.

7.     Competent and willing to consent via written informedconsent to participate in the trial including drug testing,screening tests and follow up.

8.     Willing to abstain from tobacco use during inpatientperiods.

9.     Willing to abstain from Methamphetamine during trialinpatient period.

10. Must return a negative breath alcohol test at Screening and Day -1 (repeat testing and inclusion is allowed at the discretion of the investigator).

11. Must return a negative urine drug test at Screening and Day -1 (positive result for methamphetamine excepted; repeat testing allowed at the discretion of the investigator. A participant with positive results for cannabinoids, benzodiazepines will be allowed at the discretion of the investigator).

12. Participant is deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.

13. Healthy, ambulatory participant able to understand and willing to comply with study procedures, study restrictions and requirements.

14. Voluntarily provides signed, written, and dated informed consent prior to any study-specific procedures

15. If volunteer is female and of childbearing potential, is willing and able to use an acceptable form of contraception for the duration of the study.

16. Does the Principle Investigator or delegate consider this participant to be suitable for the study?

Exclusion Criteria:

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-5 Criteria / Appendix A).

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. Positive serum or urine pregnancy test at Screening or Day-1 in female volunteers of childbearing potential. A plan to become pregnant during the course of the study.

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