Extended-release injectable suspension naltrexone (XR-NTX) as an adjunct pharmacotherapy for prevention of drug use in patients with substance use disorder in treatment for ADHD

Phase 1

• Conditions: Amphetamine dependence and ADHD (Attention-Deficit/HyperactivityDisorder); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-004710-95-SE
• Lead Sponsor: Beroendecentrum Stockholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-10
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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
days) in the last 30 days as defined by self-report and/or by urine
toxicology
6) One negative urine sample (amphetamine, cocaine, opiates, THC and
benzodiazepines) and
negative alcohol breathalyser test within four days prior to the day of
inclusion
7) One negative urine sample for opiates (dip stick test) immediately
prior to administering the first
dose of study medication
8) Address and telephone in the metropolitan area of each participating
centre, respectively, where the
participant can be reached
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 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
10) Likely to receive opioid analgesics in the next 6-months associated with possible or scheduled surgery or procedure
11) Use of an investigational agent in the last 30 days
11) Subjects with a body abnormality precluding the use of the customized needle for intramuscularinjection, based on clinical judgement

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified