altrexone for the treatment of amphetamine dependence: a randomised placebo controlled trial

Not Applicable

Completed

• Conditions: Amphetamine abuse and dependence; Mental and Behavioural Disorders; Amphetamine dependence

• Registration Number: ISRCTN29945787
• Lead Sponsor: Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)

Brief Summary

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18765480 (added 31/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-06-23
• Study Start: 2007-11-16
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Adult male or female between 18 to 65 years
2. Written, informed consent to participate
3. Address and telephone in the Stockholm metropolitan area where the participant can be reached
4. Amphetamine dependence according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
5. Having used amphetamine on a minimum of 12 occasions during the 12 weeks prior to screening
6. Two consecutive urine tests with no traces of amphetamine following screening

Exclusion Criteria

1. Opiate abuse or dependence
2. Use of any opiate preparation (legal or illicit) during 30 days prior to screening
3. Presence of opiates in urine at screening
4. Other mental disorders than substance abuse/dependence considered to be severe and requiring treatment (dementia, severe depression with suicidal ideation, acute psychotic symptoms, schizophrenia - concurrent pharmacological treatment for depression, and mild psychotic symptoms such as paranoid ideation or other forms of milder delusions for which the patient has some degree of insight do not constitute exclusion criteria)
5. Ongoing treatment with benzodiazepines
6. Acute withdrawal symptoms at screening, irrespective of cause
7. Serious somatic disorder (e.g., cancer, moderate to severe hypertension, advanced atherosclerosis, liver cirrhosis, or other disorders considered to be a risk)
8. Known hypersensitivity to naltrexone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of the study was abstinence from amphetamine use, as measured by negative amphetamine urine samples during 12 weeks of treatment (maximum of 24 samples). All missing urine samples were imputed as positive in the analysis. The primary analysis was carried out according to the Intention-To-Treat (ITT) approach.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcomes measures included the following:<br> 1. Self reported use of amphetamine (as measured by Timeline Follow Back)<br> 2. Self reported use of alcohol and other drugs of abuse (as measured by Timeline Follow Back)<br> 3. Compliance to treatment, defined as:<br> 3.1. 16/24 urine samples<br> 3.2. Medication compliance, detected by the presence of 6-ß-naltrexol in the urine<br> 3.3. Pill counts<br> 4. Craving for amphetamine, measured by the amphetamine craving scale<br> 5. Adverse events, monitored by the study physician and weekly self-report by patient<br><br> All secondary outcome measures were evaluated on a weekly basis.<br>