ISRCTN15079632进行中（未招募）1 期
Randomised, placebo-controlled functional evaluation of INDV-2000 effects on cue reactivity in opiate dependence: An fMRI study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Males or females with a diagnosis of OUD who are clinically stable with no new signs or symptoms for at least 1 month on take-home methadone treatment with no dose increase in the last 10 days prior to screening;
- •2.Agreed 18 – 65 years of age, inclusive;
- •3.BMI of 18.0 to 35.0 kg/m², inclusive (minimum weight of at least 50.0 kg at Screening);
- •4.Males who are sexually active with individuals who are of childbearing potential, and females who are of childbearing potential, must agree to use at least one medically acceptable form of contraception;
- •5.Females of childbearing potential must not be pregnant as confirmed by a negative serum and/ or urine hCG test at screening;
- •6.Females of childbearing potential must not be lactating; and
- •7.Participants must be able to give written consent (including verbalise understanding of the consent form); be willing and likely to complete all study procedures; be able to comply with the protocol requirements and site procedures
排除标准
- •1.Take over 120 mg/day of prescribed methadone;
- •2.Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder (current severe mental health disorder excluding opiate dependence) as judged by an Investigator
- •3.Use regular prescription medications which in the opinion of the investigators will interfere with participant safety or study integrity. Regular use of psychotropic medication will be permitted e.g., antidepressants, provided the participant is compliant with administration and the investigators concur that they will not interfere with participant safety or study integrity
- •4.Have clinically significant abnormal biochemistry, haematology or urinalysis results
- •5.Have a history of narcolepsy, cataplexy or obstructive or central sleep apnoea
- •6.Have disorders that may interfere with drug ADME processes
- •7.Tests positive for HIV-1/HIV-2 antibodies, and/or has serological evidence of active Hepatitis B or Hepatitis C infection
- •8.Have serious cardiac illness or other cardiac assessments including, but not limited to:
- •8.1.Uncontrolled arrhythmias
- •8.2.History of congestive heart failure (CHF)
- •8.3.Myocardial infarction in the last 6 months
- •8.4.Uncontrolled symptomatic angina
- •8.5.QTcF > 460 ms for males and >480 ms for females or history of prolonged QT syndrome
- •9.Have current active hepatic or biliary disease, including participants with cholecystectomy <90 days prior screening
- •10.Have received concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to screening
- •11.Have received drugs that are moderate or strong inhibitors/inducers of CYP3A4 or CYP2C19, including St. John’s Wort, within 30 days prior to first dose of IMP
- •12.Have a history of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering yes” to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
- •13.Have known allergy or hypersensitivity to IMP or its excipients
- •14.Are affiliated with, or a family member of, site staff directly involved in the study, or anyone with a financial interest in the outcome of the study
- •15.Currently have severe substance dependence disorder for any other substance except for opiates and nicotine. Lifetime history of dependence on other substances will be allowed given very high incidence of co-dependence.
- •16.Are regular on-top user of heroin or other opiates or other illicit substances in combination with methadone, which in the opinion of the investigators will interfere with participant safety or study integrity
- •17.Have a blood pressure reading outside of the following range: Systolic 159 mmHg; Diastolic 99 mmHg
- •18.Have any combination of the following at screening:
- •18.1TBL =1.5x ULN (with direct bilirubin >1.3 mg/dL)
- •18.2ALT =3x ULN
- •18.3AST =3x ULN
- •18.4serum creatinine >2x ULN
- •18.5or INR >1.2x ULN
- •19.Have received any prior treatment with a buprenorphine injection at least 1 year prior to randomisation
- •20.Currently incarcerated or pending incarceration/legal action that could prevent participation or compliance in the study
- •21.Contraindication to MRI based on the standard MRI screening questionnaire. Contraindications include, but not limited to, certain ferr
研究者
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