The effect of baclofen on methamphetamine dependent subjects.

Phase 2

Recruiting

• Conditions: Methamphetamine Addiction; Mental Health - Addiction; Neurological - Other neurological disorders

• Registration Number: ACTRN12616001614482
• Lead Sponsor: inear Clinical Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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.

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 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.
11.Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant returning for follow-up visits on schedule.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in activation of the mesolimbic dopaminergic system in response to methamphetamine drug cues in methamphetamine dependent patients will be measured by fMRI scanning.[Measured at day 7 of treatment with baclofen or placebo ]

Secondary Outcome Measures

Name	Time	Method
Differences in methamphetamine cravings assessed on daily assessment on a 1-10 scale between the baclofen vs placebo groups.[Measured daily in the first 7 days (while in the clinical trials unit) and at 5 weeks from commencement of baclofen or placebo.];The difference in methamphetamine use between patients on baclofen vs no medication measured by per self reported use and urine drug screening .[Measured at 3, 6, 9 and 12 months post commencement of the trial.]