A randomised (non-blinded) trial comparing the clinical efficacy of naltrexone implant plus Cognitive Behavioral Therapy versus Cognitive Behavioral Therapy in the management of problem amphetamine use

Phase 2

Suspended

• Conditions: Amphetamine addiction; Mental Health - Addiction

• Registration Number: ACTRN12618000568213
• Lead Sponsor: Go Medical Industries Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants must be aged 18 years or older, satisfy DSM-V Substance Use Disorder diagnostic criteria for amphetamine-type stimulant use, be willing and able to provide written informed consent to participate in the randomised trial treatment, have resided in Western Australia for at least 26 weeks prior and intend to reside in Western Australia for at least 26 weeks after treatment, hold a valid Australian Medicare card and agree to undergo fortnightly urinalysis and be contacted by phone fortnightly for the 26 week duration of follow-up. Additionally, women should be using appropriate birth control and may be required to provide a negative pregnancy screen prior to recruitment .

Exclusion Criteria

Any person who in the last six months was or currently is enrolled in any other research study, is pregnant, breastfeeding or plans for pregnancy in the next 12 months, unable to complete the study protocol e.g. unwilling to co-operate with study follow-up, pain that requires narcotic treatment, medical disorder that in the opinion of the clinician places the subject at increased risk from any study treatment, active skin or other infection that would increase risk of infection at the site of implantation and any current major psychiatric condition preventing the patient from providing informed consent. Participants will be naltrexone implant naïve or have not undergone naltrexone implant in the previous 18 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified