A Telephone-delievered Intervention to Reduce Methamphetamine Use

NCT ID: NCT04713124

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2024-01-25

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.

Conditions

Methamphetamine Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

R2C-M intervention

R2C-M telephone intervention - Six approximately weekly sessions of R2C-M telephone-delivered intervention (50 minutes in duration), delivered by the same R2C-M Counsellor each session (a qualified clinical psychologist trained in the R2C protocol by the developer, Dr Kate Hall). Call duration will be recorded. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants.

R2C-M workbooks - Two workbooks to facilitate counsellor-delivered exercises within sessions, and between-session practice, will be mailed/emailed to participants.

Self-help booklet - (as in control group) R2C-M participants will also receive a booklet of information and self-help strategies for methamphetamine use problems.

Group Type: EXPERIMENTAL

R2C-M

Intervention Type: BEHAVIORAL

R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.

Self-help booklet

Intervention Type: OTHER

A booklet of information and self-help strategies for methamphetamine use problems.

Control

Self-help booklet - Control participants will receive (by mail/email) a booklet of information and self-help strategies for methamphetamine use problems.

Telephone check-ins + information on further support - (to control for frequency of contact across treatment arms) Participants in this group will receive 6 telephone calls from the research team (lasting maximum 5 minutes, call duration will be recorded). During these calls, participants will be asked about their use of the booklet. Whenever required, the researcher will provide participants with information on further support (e.g. DirectLine or other state/territory AOD helpline for advice or referral).

Group Type: ACTIVE_COMPARATOR

Self-help booklet

Intervention Type: OTHER

A booklet of information and self-help strategies for methamphetamine use problems.

Interventions

R2C-M

R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.

Intervention Type: BEHAVIORAL

Self-help booklet

A booklet of information and self-help strategies for methamphetamine use problems.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Health

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

Deakin University

OTHER

Sponsor Role: collaborator

Turning Point

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan I Lubman

Role: PRINCIPAL_INVESTIGATOR

Turning Point, Eastern Health; Monash University

Locations

Turning Point

Richmond, Victoria, Australia

Countries

Australia

References

Lubman DI, Manning V, Arunogiri S, Hall K, Reynolds J, Stragalinos P, Petukhova R, Gerhard R, Tyler J, Bough A, Harris A, Grigg J. A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial. Trials. 2023 Mar 29;24(1):235. doi: 10.1186/s13063-023-07172-9.

Reference Type: DERIVED

PMID: 36991490 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

E20/011/61428

Identifier Type: -

Identifier Source: org_study_id