Additction Recovery Clinic (ARC) - Adaptive Maintenance Treatment for Opioid Use Disorder.
- Conditions
- Opiate dependency disorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-002237-11-GB
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method