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临床试验/ACTRN12616001614482
ACTRN12616001614482招募中2 期

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

inear Clinical Research Ltd0 个研究点目标入组 18 人开始时间: 2016年11月22日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 40 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
inear Clinical Research Ltd

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