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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04713124




Registration number
NCT04713124
Ethics application status
Date submitted
11/01/2021
Date registered
19/01/2021

Titles & IDs
Public title
A Telephone-delievered Intervention to Reduce Methamphetamine Use
Scientific title
Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use
Secondary ID [1] 0 0
E20/011/61428
Universal Trial Number (UTN)
Trial acronym
R2C-M
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - R2C-M
Other interventions - Self-help booklet

Experimental: 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.

Active comparator: 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).


BEHAVIORAL: 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.

Other interventions: Self-help booklet
A booklet of information and self-help strategies for methamphetamine use problems.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Methamphetamine problem severity
Timepoint [1] 0 0
3-months post-randomisation
Secondary outcome [1] 0 0
Methamphetamine problem severity
Timepoint [1] 0 0
6- and 12-months post-randomisation
Secondary outcome [2] 0 0
Number of methamphetamine use days
Timepoint [2] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [3] 0 0
Amount of methamphetamine used
Timepoint [3] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [4] 0 0
Number of DSM-5 methamphetamine use disorder criteria met
Timepoint [4] 0 0
3-, 6- and 12-months post-randomisation
Secondary outcome [5] 0 0
Methamphetamine craving
Timepoint [5] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [6] 0 0
Psychological functioning
Timepoint [6] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [7] 0 0
Psychotic-like experiences
Timepoint [7] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [8] 0 0
Quality of life
Timepoint [8] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [9] 0 0
Days of other drug use
Timepoint [9] 0 0
6 weeks, and 3-, 6- and 12-months post-randomisation
Secondary outcome [10] 0 0
Cost-effectiveness - QALYs
Timepoint [10] 0 0
Over 12 months
Secondary outcome [11] 0 0
Cost-effectiveness - health care costs
Timepoint [11] 0 0
Over 12 months
Secondary outcome [12] 0 0
Cost-effectiveness - work-related losses
Timepoint [12] 0 0
Over 12 months
Secondary outcome [13] 0 0
Adverse events
Timepoint [13] 0 0
Up to 6 weeks post-randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2024
Sample size
Target
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Turning Point - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Other
Name
Turning Point
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eastern Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Deakin University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dan I Lubman
Address 0 0
Turning Point, Eastern Health; Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Ethics approval to seek patient permission to share data outside this study, other than for related projects conducted by the research team.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04713124