Amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder)
Conditions
Interventions
Trade Name: vivitrol
Product Name: Naltrexone
Pharmaceutical Form: Injection
INN or Proposed INN: NALTREXONE
CAS Number: 16590-41-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Beroendecentrum Stockholm
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of naltrexone as relapse prevention for substance use in patients with ADHD who are currently using central stimulant medication.;Secondary Objective: Proportion of urine samples free of drugs of abuse (with the exclusion of THC), (ITT and completers analysis) without imputing missing data Proportion of urine samples free of THC (qualitative measure; below the laboratory's standard cutoff) in all randomized participants who took at least 1 study medication dose (ITT) Time to first relapse (first positive urine toxicology; any of tested drugs) Self-reported days of drug and alcohol use as measured by TLFB Proportion of urine samples positive of benzodiazepines Craving as measured by VAS scale Depression rating as measured by MADRS-S Scale Levels of NTX and its metabolite in plasma and correlation with measures of drug use, craving and side effects over the course of treatment Levels of ASAT and ALAT Levels of PEth Cognitive function as measured by CANTAB between 2 treatment arms Change in observer-rated ADHD-symptoms as measured with Conners' Adult ADHD Scale Observer version (CAARS-O: SV);Primary end point(s): a) Proportion of urine samples free of drugs, where missing urine data is considered as a positive sample (with the exclusion of THC), with intention-to-treat analysis and completers analysis, respectively. b) Percent of heavy drinking days defined as five or more drinks for men, four or more for women assessed by TLFB. c) Change in self-rated ADHD symptoms as measured by the Adult ADHD self-report scale (ASRS v. 1.1) in all participants who took at least the 1st study medication dose.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of urine samples free of drugs of abuse (with the exclusion of THC), in all randomized participants who took at least 1 study medication dose (ITT and completers analysis) without imputing missing data for positives Proportion of urine samples free of THC (qualitative measure; below the laboratory's standard cutoff) in all randomized participants who took at least 1 study medication dose (ITT) Time to first relapse (first positive urine toxicology; any of tested drugs) Self-reported days of drug and alcohol use as measured by TLFB Proportion of urine samples positive of benzodiazepines Craving as measured by VAS scale Depression rating as measured by MADRS-S Scale Levels of NTX and its metabolite in plasma and correlation with measures of drug use, craving and side effects over the course of treatment Levels of ASAT and ALAT to evaluate medication safety and tolerability- Levels of PEth to monitor heavy alcohol use Cognitive function as measured by CANTAB between 2 treatment arms Change in observer-rated ADHD-symptoms as measured with Conners' Adult ADHD Scale Observer version (CAARS-O: SV) Drug and alcohol use as measured by TLFB at the follow-up period, post 12 weeks treatment.;Timepoint(s) of evaluation of this end point: LPLV | — |
Countries
Sweden
Contacts
Public ContactMagnus Huss clinic
Beroendecentrum Stockholm
Outcome results
None listed