Methamphetamine Use DisorderR2C-MNCT04713124
A Telephone-delievered Intervention to Reduce Methamphetamine Use
A study testing R2C-M and Self-help booklet in people with Methamphetamine Use Disorder, run by Turning Point at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- R2C-M and Self-help booklet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Feb 2021to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use
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
- Being tested
- R2C-M, Self-help booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R2C-MBehavioural
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 bookletOther
A booklet of information and self-help strategies for methamphetamine use problems.
| Study group | Role | What they receive |
|---|---|---|
| R2C-M intervention | Experimental | 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. Receives: Behavioral: R2C-M; Other: Self-help booklet |
| Control | Active comparator | 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). Receives: Other: Self-help booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methamphetamine problem severity
Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)
Measured: 3-months post-randomisation
Secondary outcomes (13)
Methamphetamine problem severity
Change in methamphetamine problem severity (DUDIT)
Measured: 6- and 12-months post-randomisation
Number of methamphetamine use days
Change in number of methamphetamine use days (Timeline Followback; TLFB)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Amount of methamphetamine used
Change in amount of methamphetamine used (TLFB)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Number of DSM-5 methamphetamine use disorder criteria met
Change in the number of DSM-5 methamphetamine use disorder criteria met (Structured Clinical Interview for DSM-5 Disorders - Research Version; SCID-5-RV)
Measured: 3-, 6- and 12-months post-randomisation
Methamphetamine craving
Change in craving for methamphetamine (Craving Experience Questionnaire; CEQ)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Psychological functioning
Change in psychological functioning (Depression Anxiety and Stress Scale; DASS-12)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Psychotic-like experiences
Change in psychotic-like experiences (Community Assessment of Psychic Experiences 15, CAPE15)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Quality of life
Change in quality of life (EUROHIS-QOL single item)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Days of other drug use
Change in days of other drug use (TLFB)
Measured: 6 weeks, and 3-, 6- and 12-months post-randomisation
Cost-effectiveness - QALYs
Difference in quality-adjusted life years (QALYs) (abridged version of the 5-level EQ-5D version, EQ-5D-5L+)
Measured: Over 12 months
Cost-effectiveness - health care costs
Difference in health care costs (3Mg Health-care Resource Use Questionnaire)
Measured: Over 12 months
Cost-effectiveness - work-related losses
Difference in work-related losses (World Health Organization Health and Performance Questionnaire Clinical Trials Version; WHO HPQ28-Day)
Measured: Over 12 months
Adverse events
Occurrence of adverse events (AEs) and significant adverse events (SAEs)
Measured: Up to 6 weeks post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start4 Feb 2021
- Primary completion1 May 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health, Monash University, Deakin University
- Responsible party
- Sponsor
- Investigators
- Dan I Lubman, Principal investigator, Turning Point, Eastern Health; Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713124
- Sponsor's protocol ID
- E20/011/61428
- Acronym
- R2C-M
- Status last verified
- Aug 2025
- First submitted
- 11 Jan 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Ethics approval to seek patient permission to share data outside this study, other than for related projects conducted by the research team.
Publications
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.
PubMed 36991490
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use
- ClinicalTrials.gov ID
- NCT04713124
- Acronym / sponsor ID
- R2C-M / E20/011/61428
- Conditions
- Methamphetamine Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Turning PointUniversity, hospital or other
- Collaborators
- Eastern Health, Monash University, Deakin University
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| R2C-M intervention | Experimental | Behavioral: R2C-M, Other: Self-help bookletR2C-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. |
| Control | Active comparator | Other: Self-help bookletSelf-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R2C-MR2C-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. | Behavioural | R2C-M intervention |
| Self-help bookletA booklet of information and self-help strategies for methamphetamine use problems. | Other | Control, R2C-M intervention |
Primary outcome
Methamphetamine problem severity
Time frame: 3-months post-randomisation
Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)
13 secondary outcomes
Methamphetamine problem severity
Time frame: 6- and 12-months post-randomisation
Number of methamphetamine use days
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Amount of methamphetamine used
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Number of DSM-5 methamphetamine use disorder criteria met
Time frame: 3-, 6- and 12-months post-randomisation
Methamphetamine craving
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Psychological functioning
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Psychotic-like experiences
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Quality of life
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Days of other drug use
Time frame: 6 weeks, and 3-, 6- and 12-months post-randomisation
Cost-effectiveness - QALYs
Time frame: Over 12 months
Cost-effectiveness - health care costs
Time frame: Over 12 months
Cost-effectiveness - work-related losses
Time frame: Over 12 months
Adverse events
Time frame: Up to 6 weeks post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 36991490Lubman 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.
- Individual participant dataSharing planned: No. No Ethics approval to seek patient permission to share data outside this study, other than for related projects conducted by the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan I Lubman principal investigator
Turning Point, Eastern Health; Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R2C-M and Self-help booklet in people with Methamphetamine Use Disorder, run by Turning Point at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methamphetamine problem severity (time frame: 3-months post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04713124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.