Extended-release injectable suspension naltrexone (XR-NTX) as an adjunt pharmacotherapy for prevention of substance use in patients with SUD who are currently in treatment for ADHD: A multicenter randomized placebo-controlled trial. - REPAS (Relapse prevention in ADHD/SUD)

Beroendecentrum Stockholm0 sites128 target enrollmentJanuary 10, 2017

Drugsvivitrol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Beroendecentrum Stockholm
Enrollment: 128
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 10, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Beroendecentrum Stockholm

Eligibility Criteria

Inclusion Criteria

•1\) Adult male or female aged 18\-70 years
•2\) Written, informed consent to participate
•3\) Fulfil DSM\-5 criteria for ADHD
•4\) Ongoing central stimulant pharmacotherapy (e.g. methylphenidate,
•amphetamines) for ADHD,
•irrespective of duration or dose, formulation or brand.
•5\) Fulfil DSM\-5 criteria for alcohol use disorder, and/or stimulant use
•disorder, and/or opioid use
•disorder, having a minimum of 2 relapses (\=drug use on two separate
•days, and/or two heavy drinking

Exclusion Criteria

•1\) Current DSM\-5 diagnosis of severe opioid substance use disorder,
•2\) Manifestation of withdrawal symptoms or reports of current withdrawal symptoms of opioids
•3\) Current psychiatric condition considered by the study physician to be severe and/or unstable (e.g., psychosis, schizophrenia, bipolar, suicidal or homicidal)
•4\) Known or suspected use of any opioid medication or illicit opiates in the last 7 days prior to inclusion
•5\) Ongoing benzodiazepine pharmacotherapy (medically motivated doses for e g withdrawal treatment during the trial do not constitute a reason for exclusion)
•6\) Somatic disorder (e.g., cancer, seizure disorder, severe hypertension and liver cirrhosis) determined to be serious in the clinical judgement of the study physician
•7\) Acute hepatitis or liver damage as evidenced by serum aspartate (AST) or alanine aminotransferase (ALT) concentration greater than three times the upper normal reference range, or serum bilirubin greater than 10% above the upper normal limit.
•8\) Female subjects who are pregnant or lactating or of child bearing potential who are not using acceptable methods of birth control. Specified as combined hormonal contraception associated with inhibition of ovulation (orally, intravaginal or transdermal), progesterone\-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
•implantable), intrauterine device (IUD), intrauterine hormone\-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, condom or sexual abstinence.
•9\) Known hypersensitivity to naltrexone, polylactide\-co\-glycolide (PLG), carboxymethylcellulose or any other compounds of the diluent