altrexone Enhanced Addiction Treatment (NEAT)

Not Applicable

Completed

• Conditions: Topic: Mental Health; Subtopic: Addictions; Disease: Addictive Substances– illegal drugs; Mental and Behavioural Disorders

• Registration Number: ISRCTN95809946
• Lead Sponsor: King's College London

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30702059 [added 01/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2016-05-31
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion criteria for the study are intended to be as close to clinical practice as possible. Each participant in the trial must meet all of the following criteria:
1. Is 18 years of age or older
2. Has been given 48 hours to consider and demonstrate 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.
3. Has a diagnosis of opioid use disorder (heroin; DSM-5: past 12 months), based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, using the MINI Neuropsychiatric Interview (version 6) conducted at baseline.
4. Is completing or has recently completed an inpatient or outpatient treatment for opioid detoxification, or has been completely and continuously abstinent from all opioids for at least seven days.
5. Has no tolerance to opioids, as verified by a negative urine toxicology screening test prior to randomisation (using a Morphine 2000 [opioid class] instant result immunoassay device).
6. Passes a naloxone challenge test (to confirm zero opioid tolerance by demonstrating no clinical sign or subjective report of opioid withdrawal before randomisation and prior to implant procedure) NB: Individuals failing screening will be allowed to enter screening once more (only) after one month.
7. Is voluntarily seeking opioid antagonist treatment for opioid use disorder.
8. Lives in stable/secure accommodation in the community.
9. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required.
10. If female, is not pregnant or breast feeding and agrees to use a birth control method (either oral hormonal contraceptives, barrier [condom or diaphragm], or Nexplanon implant) for the duration of the study

Exclusion Criteria

Otherwise eligible individuals who meet any of the following criteria will be excluded from the study:
1. Clinically significant medical condition or observed abnormalities on physical examination or laboratory investigation, including but not limited to: Uncontrolled hypertension; Significant heart disease (including angina and myocardial infarction in past 12 months)
Any ECG/cardiovascular abnormality which, in the investigator’s judgment, is clinically significant
2. Severe alcohol dependence and/or alcohol intoxication (breathalysed alcohol level <0.35); or alcohol withdrawal
3. Positive naloxone challenge test at randomization (confirming opioid use).
4. Active hepatitis or aspartate aminotransferase, alanine aminotransferase (>3x the upper limit of the normal range)
5. Currently taking oral or depot naltrexone therapy or enrolment in any form of naltrexone therapy within 90 days prior to study screening
6. Current criminal justice involvement with legal proceedings (not including current probationary supervision) and, in the opinion of the clinical worker is expected to fail to complete the study protocol due to re-incarceration or relocation from the centre’s catchment area
7. Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt
8. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of opioid negative urines; Timepoint(s): 12 week post randomisation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adherence; Timepoint(s): end of trial<br> 2. Self-reported heroin use via Time-Line Follow-Back (TLFB) interview; Timepoint(s): 16, 24 and 36 weeks<br> 3. Treatment retention; Timepoint(s): end of trial<br>