Amphetamine dependence
Conditions
Interventions
Trade Name: Naltrexon
Pharmaceutical Form: Tablet
INN or Proposed INN: NALTREXONE
CAS Number: 16590413
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceu
Sponsors
Beroendecentrum Stockholm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men between the ages 20-55 years Fulfils DSM-IV diagnosis for amphetamine dependence Minimum of 2 years history of amphetamine dependence History of intravenous amphetamine use Consumed amphetamine for minimum of 12 times in the last 12 weeks Drug free 1-30 days (minimum 24 hours) Abstinent from nicotine and caffeine during the testing day A healthy control group is also selected according to the following inclusion criteria: Men between 20-55 years, judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs. 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Fulfils DSM-IV diagnosis of any other substance dependence disorder (except nicotine) Fulfils DSM-IV diagnosis of any major psychiatric illness (e.g. bipolar affective disorder, schizophrenia) Left-handedness No clinical signs of amphetamine intoxication at the day of testing Traces of cannabis, opiates, cocaine or benzodiazepines in the urine at the day of testing Traces of alcohol as measured by breathalyser at the day of testing Implant of pacemaker or any metallic object that might interfere with the magnetic field Presence of severe somatic disorder (e.g. renal or hepatic failure) Regular use of medication that may interact with study medication (e.g., opioid pain killers) Experience with naltrexone during last six months Known hypersensitivity to naltrexone The healthy control group will be selected according to the following exclusion criteria: Fulfils DSM IV diagnosis of any substance dependence disorder in self or in first degree relatives (parents, children or siblings) Smoker (including snuff or any other nicotine product) and fulfils DSM IV diagnosis of nicotine dependence Fulfils DSM IV diagnosis of any major psychiatric illness in self or in first degree relatives (parents, children or siblings) Left-handedness Traces of cannabis, opiates, cocaine, central amines or benzodiazepines in the urine at test day Traces of alcohol as measured by breathalyzer at test day Implant of pacemaker or any metallic object that might interfere with the magnetic field Use of any concomitant medication Known hypersensitivity to naltrexone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluating the effects of naltrexone on reward function and processing of amphetamine-related cues in amphetamine dependent patients, using functional magnetic resonance imaging.;Secondary Objective: Comparison of reward processing between amphetamine dependent patients and healthy controls. Evaluation of the effect of naltrexone on pain processing in healthy controls.;Primary end point(s): fMRI BOLD signal in the brain reward system during exposure to amphetamine-related cues of different kinds. Functional connectivity as measured by fMRI.;Timepoint(s) of evaluation of this end point: During cue presentation in the MR camera, at least 60 minutes after intake of study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Behavioral data on subjective craving and experience of pain.;Timepoint(s) of evaluation of this end point: Immediately after cue presentations and painful stimuli, respectively. | — |
Countries
Sweden
Contacts
Public ContactCentrum för psykiatriforskning
Karolinska Institutet
Outcome results
None listed