ISRCTN06774607
Completed
Not Applicable
Effectiveness of adaptive opioid agonist maintenance pharmacotherapy and behavioural therapy for opioid use disorder
King's College London (UK)0 sites600 target enrollmentMarch 4, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opiate dependency
- Sponsor
- King's College London (UK)
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 18 years of age or older
- •2\. Is able to comprehend English to the extent required by the study protocol
- •3\. 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
- •4\. Current diagnosis of opioid dependence
- •5\. Current opioid tolerance
- •6\. Voluntarily seeking treatment for opioid dependence and able to attend the clinic as described in the protocol
- •7\. Lives in sufficiently stable accommodation in the community, with a personal phone
- •8\. 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
Exclusion Criteria
- •1\. Clinically significant medical condition (including pregnancy or lactating) or observed abnormalities on physical examination or laboratory investigation, 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 ECG/cardiovascular abnormality which, in the investigator?s judgment, is clinically significant.
- •2\. 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.
- •3\. Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt.
- •4\. 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.
- •5\. Is not currently a participant in a research study or has not been in CTIMP research study in the previous 4 months
Outcomes
Primary Outcomes
Not specified
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