Clinical trial NCT04713124: A Telephone-delievered Intervention to Reduce Methamphetamine Use
Official title: Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Use Disorder
Lead sponsor: Turning Point
Sponsor class: OTHER
Collaborators: name: Eastern Health
name: Monash University
name: Deakin University
First posted: 2021-01-19
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Australia has one of the highest rates of methamphetamine use in the world; however, uptake of face-to-face psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service availability, geography) barriers to accessing care. Addressing these barriers through the provision of alternative treatment delivery models is imperative, particularly as effective and earlier intervention is likely to reduce the need for more costly and intensive treatment resulting from escalating methamphetamine use.

In this project, the investigators will conduct the first double-blind, parallel-group, randomised controlled trial (RCT) examining the effectiveness of the structured telephone-delivered intervention, Ready2Change (R2C), among participants with methamphetamine use problems (R2C-M). Cost effectiveness of R2C-M will also be investigated. Factors influencing program implementation will be evaluated to inform the scalability of this intervention for practice nationally, and for replication internationally.


Eligibility criteria: Inclusion Criteria:

* Age 18+ years
* Mild or moderate methamphetamine use disorder (DSM-5 diagnosis confirmed at baseline assessment using the Structured Clinical Interview for DSM-5 Disorders - Research Version, SCID-5-RV)
* Used methamphetamine on at least two occasions in the past month
* Seeking to reduce methamphetamine use
* Able to provide informed consent, and comply with the requirements of the treatment protocol
* Willing to provide the contact details of their general practitioner or other treating physician, for follow-up
* English as a first language or fluent
* Educated to high school level (literacy)
* Regular access to a telephone
* Postal/email address to receive intervention materials

Exclusion Criteria:

* Currently receiving treatment for substance use disorder (e.g. medically supervised detoxification, residential rehabilitation, drug counselling, pharmacotherapy - this criterion applies only at trial enrolment, and does not preclude the participant from entering treatment/receiving usual care during the trial)
* Requiring acute care for severe substance use disorder (DSM-5 diagnosis confirmed at baseline using the SCID-5-RV, with oversight from the Principal Investigator or Study Clinician)
* Requiring acute care for active suicidality or unstable psychiatric condition
* A diagnosed primary psychotic disorder (schizophrenia, schizoaffective disorder, bipolar disorder)
* Pregnancy
* Hearing impairment that would prohibit participation in telephone intervention / follow-up assessments

Primary outcomes:
measure: Methamphetamine problem severity
timeFrame: 3-months post-randomisation
Secondary outcomes:
measure: Methamphetamine problem severity
timeFrame: 6- and 12-months post-randomisation
measure: Number of methamphetamine use days
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Amount of methamphetamine used
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Number of DSM-5 methamphetamine use disorder criteria met
timeFrame: 3-, 6- and 12-months post-randomisation
measure: Methamphetamine craving
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Psychological functioning
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Psychotic-like experiences
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Quality of life
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Days of other drug use
timeFrame: 6 weeks, and 3-, 6- and 12-months post-randomisation
measure: Cost-effectiveness - QALYs
timeFrame: Over 12 months
measure: Cost-effectiveness - health care costs
timeFrame: Over 12 months
measure: Cost-effectiveness - work-related losses
timeFrame: Over 12 months
measure: Adverse events
timeFrame: Up to 6 weeks post-randomisation
Other outcomes:
measure: Program evaluation
timeFrame: Through study completion, approximately 28 months
Locations:
city: Richmond
country: Australia
facility: Turning Point
state: Victoria
Study officials:
affiliation: Turning Point, Eastern Health; Monash University
name: Dan I Lubman
role: PRINCIPAL_INVESTIGATOR
References: