Linear Clinical Research Current Trials Menu

Baclofen Trial


Linear Clinical Research is an award-winning medical research facility located at QEII Medical Centre in Perth. They are conducting a study on the effect of baclofen vs placebo on the activation of the mesolimbic dopaminergic system in methamphetamine dependent subjects: fMRI study.

Methamphetamine addiction is a major and growing problem in Australia, with a considerable individual, family and community burden. The current trend is a rapid increase in the use of crystal methamphetamine, the most addictive form, from 10% of users in 2010 to over 50% in 2014. Current treatment options for methamphetamine addiction are all based on Cognitive Behavioural Therapy (CBT) and have very low rates of durable abstinence.

Linear Clinical Research Ltd, is testing Baclofen to establish if Baclofen has an anti-craving action in methamphetamine. To test this anti-craving action, Magnetic Resonance Images (MRI) of brain activation will be assessed in Baclofen treated participants compared to placebo. Participants in the study will continue to take Baclofen for 28 days after an initial 7 days in the Linear Clinical Research unit. After this time, they will be offered the option of taking Baclofen for another 11 months to complete the study period to
assess the effect of Baclofen on cravings over this time period. This study does not provide any remuneration for its participants. Participants are required to stay in Linear’s clinic for 7 days.

To qualify for this trial, candidates must pass the inclusion and exclusion criteria. See below for some of the criteria included.


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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