Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management

Table 1

Participant inclusion and exclusion criteria.

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Inclusion criteria

For a participant to be enrolled into the study he must fulfil all the following inclusion criteria:

(1) Aged 18 and above with no upper limit (usually 64 years);

(2) Current diagnosis of OUD;

(3) Voluntarily seeking OAT treatment;

(3) Resident in the UAE;

(4) Evidence of stable accommodation.

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Exclusion criteria

Otherwise eligible patients will be excluded from the study for any of the following:

(1) Benzodiazepine use in excess of 20 mg daily diazepam equivalent in the past 28 days;

(2) Known naloxone or BUP hypersensitivity;

(3) Pregnancy;

(4) Hepatic impairment (elevation of liver function tests three times normal);

(5) Suicide attempt in past 12 months;

(6) Involvement in criminal justice system which is likely to result in arrest and incarceration;

(7) Uncontrolled severe mental or physical illness judged to compromise safety;

(8) Mini Mental State Examination score < 17 indicating cognitive dysfunction.

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