Effectiveness of Adaptive Opioid Agonist Maintenance Pharmacotherapy and Behavioural Therapy for Opioid Use Disorder. - Addiction Recovery Clinic (ARC)

King's College London0 个研究点开始时间: 2012年9月18日最近更新: 2013年4月22日

试验速览

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•18 years of age or older (no upper limit, but generally <60yrs).
•Is able to comprehend English to the extent required by the study protocol
•Demonstrates verbal understanding of the study patient information material, is able to provide written consent, and can understand and confirm willingness to comply with the protocol.
•Current diagnosis of opioid use disorder (dependence)
•Current opioid tolerance
•Prescribed either methadone or suboxone
•Voluntarily seeking treatment for opioid dependence and able to attend the clinic as described in the protocol.
•Lives in sufficiently stable accommodation in the community, with a personal phone
•Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 600
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Clinically significant medical condition including but not limited to: uncontrolled hypertension; significant heart disease (including myocardial infarction in past 12 months); angina; or any serious, potentially life-threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct; or any abnormality which, in the investigator’s judgment, is clinically significant.
•Current criminal justice involvement with legal proceedings and, in the opinion of the Chief Investigator, is expected to fail to complete the study protocol due to incarceration or relocation from the centre’s catchment area.
•Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt.
•Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder – addressed in routine admissions protocol) and/or a history or evidence of organic brain disease or dementia that would compromise the participant’s ability to comply with the study protocol.
•Is not currently a participant in a research study or has been in CTIMP research study in the previous 4 months

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