Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000690459
Ethics application status
Approved
Date submitted
26/05/2025
Date registered
30/06/2025
Date last updated
30/06/2025
Date data sharing statement initially provided
30/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)
Scientific title
Feasibility and Acceptability of Acceptance and Commitment Therapy for Crystal Methamphetamine Use Disorder (ACT for ICE)
Secondary ID [1] 314492 0
None
Universal Trial Number (UTN)
Trial acronym
ACT for ICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 337536 0
Condition category
Condition code
Mental Health 333898 333898 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Recovery and Support Program (RaSP) is 45 sessions long, with 3 sessions covered twice per week over 8 weeks. Each session runs for approximately 1-hour comprising of activities, games and breaks. Some topics covered in the intervention include Present Moment Awareness, Acceptance, Defusion, Values, Committed Action and Self-as-Context. Participants receive a participant manual that they will work through and reference throughout the duration of the program. This manual has been designed for the trial and is not publicly available. The program structure has been adapted for individual delivery in a face to face format. Facilitators will be alcohol and drug clinicians with relevant experience working with individuals using methamphetamine. Adherence to the sessions will be monitored through attendance, participation and engagement.
Intervention code [1] 331116 0
Behaviour
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341607 0
Feasibility
Timepoint [1] 341607 0
consent obtained - end of study period session attendance - collected for the duration of the intervention from baseline SRS - collected for the duration of the intervention from baseline Qualitative interviews - completed between completion of the intervention and 3-month follow up post final session for participants and at the conclusion of the trial period for staff.
Primary outcome [2] 341611 0
Acceptability
Timepoint [2] 341611 0
Completeness of data assessed at the end of the intervention period for each participant qualitative interviews completed between completion of the intervention and 3-month follow up post final session for participants and at the conclusion of the trial period for staff.
Secondary outcome [1] 448075 0
Preliminary Effectiveness
Timepoint [1] 448075 0
Baseline, Final Session, 3 month follow up post final session
Secondary outcome [2] 448076 0
Interventional Change
Timepoint [2] 448076 0
Baseline, final session, 3 month follow up post final session
Secondary outcome [3] 448440 0
Preliminary Effectiveness
Timepoint [3] 448440 0
Baseline, Final Session, 3 month follow up post final session
Secondary outcome [4] 448441 0
Preliminary Effectiveness
Timepoint [4] 448441 0
Randomly generated schedule throughout the duration of the intervention from baseline to final intervention session (approx. 8 weeks).

Eligibility
Key inclusion criteria
All participants must be over the age of 18.

Meet DSM-5 criteria for primary Methamphetamine Use Disorder, moderate or severe as determined by a member of the research team.

Be female, non-binary, or woman-identifying (i.e., trans-women included)

Must be deemed to have capacity to provide informed consent and to follow study instructions and procedures (determined by the clinical judgement of program staff and the MOCA).

Ability to understand the PICF
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If the individual needs acute psychiatric care or has an unstable psychiatric condition (e.g., for suicidality or acute psychosis) that would reasonably prevent them from engaging in and/or benefiting from the intervention.

If the individual needs acute care for intoxication or in need of medically supervised detoxification that would reasonably prevent them from engaging in and/or benefiting from the intervention.

If the individual has a cognitive impairment that would reasonably prevent them from engaging in and/or benefiting from the intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 319031 0
Government body
Name [1] 319031 0
Tasmanian Department of Health
Country [1] 319031 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 321496 0
Government body
Name [1] 321496 0
Tasmanian Department of Health
Address [1] 321496 0
Country [1] 321496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317640 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 317640 0
Ethics committee country [1] 317640 0
Australia
Date submitted for ethics approval [1] 317640 0
16/05/2025
Approval date [1] 317640 0
30/05/2025
Ethics approval number [1] 317640 0
31653

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

Contacts
Principal investigator
Name 141658 0
Prof David Castle
Address 141658 0
The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
Country 141658 0
Australia
Phone 141658 0
+61 04 55049903
Fax 141658 0
Email 141658 0
[email protected]
Contact person for public queries
Name 141659 0
Eleanor Vincent
Address 141659 0
The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
Country 141659 0
Australia
Phone 141659 0
+61 04 55049903
Fax 141659 0
Email 141659 0
[email protected]
Contact person for scientific queries
Name 141660 0
Eleanor Vincent
Address 141660 0
The Tasmanian Centre For Mental Health Service Innovation, 17 Liverpool Street, Hobart, Tasmania 7000
Country 141660 0
Australia
Phone 141660 0
+61 04 55049903
Fax 141660 0
Email 141660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Letter of Approval.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.