None listed
Conditions
Brief summary
There are currently no approved pharmacological treatments for methamphetamine dependence. There is a theoretical basis that drugs similar to methamphetamine, such lisdeamfetamine, may allow dependent users to stablise their use. Currently, there is no data on what dose of lisdexamfetamine is safe for people who are habituated to methamphertamine use. This study aims to ascertain the safety of giving a higher dose, while also looking for any change in methamphetine use or risk behaviours while taking the study drug.
Interventions
The study period extends over 14 weeks, which includes a 2 week screening period, 8 weeks of treatment, and a follow up visit 4 weeks after the final dose has been administered. Dose-escalating study of oral lisdexamfetamine from a minimum of 100mg/day to a maximum of 250mg/day and then decreased over the 8 week treatment period to establish safety profile in adults with methamphetamine dependence. Study drug to be dispensed daily at study site drug treatment centre. Participants and dispens
The study period extends over 14 weeks, which includes a 2 week screening period, 8 weeks of treatment, and a follow up visit 4 weeks after the final dose has been administered. Dose-escalating study of oral lisdexamfetamine from a minimum of 100mg/day to a maximum of 250mg/day and then decreased over the 8 week treatment period to establish safety profile in adults with methamphetamine dependence. Study drug to be dispensed daily at study site drug treatment centre. Participants and dispensing staff will be aware of dose-escalation, but will be blinded as to when dose is escalated to reduce expectancy effects. Participants will also be offered weekly counseling, but participation in the trial is not contingent on this.
Sponsors
St. Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Treatment seeking for Methamphetamine (MA) dependence - Fulfils ICD-10 criteria for MA dependence - Self-reported MA use of >/= 14 days out of 28 days prior to enrolment
Exclusion criteria
- Use of dexamphetamine in the previous 4 weeks - Uncontrolled medical or psychiatric conditions - Unstable alcohol or other substance use, other than MA - Pregnant or nursing females - Moderate to severe hypertension - Sensitivity/allergy to lisdexamfetamine
Outcome results
None listed