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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05760807




Registration number
NCT05760807
Ethics application status
Date submitted
14/02/2023
Date registered
8/03/2023
Date last updated
16/07/2024

Titles & IDs
Public title
Intranasal Oxytocin for Methamphetamine Withdrawal in Women
Scientific title
An Open Label Pilot Study of Intranasal Oxytocin for Methamphetamine Withdrawal in Women
Secondary ID [1] 0 0
NCR3SF18
Secondary ID [2] 0 0
E21-014-75603
Universal Trial Number (UTN)
Trial acronym
mOXY
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
Treatment: Drugs - Oxytocin nasal spray

Experimental: Intranasal oxytocin - Participants will receive oxytocin by intranasal spray under clinician supervision (1 insufflation equating to an active dose of 24 IU) twice daily (i.e., 48 IU per day), delivered over 7 days of a residential inpatient withdrawal admission.


Treatment: Drugs: Oxytocin nasal spray
Intranasal oxytocin, administered dose 24 international units (IU) twice daily, delivered over 7 days of a residential inpatient withdrawal admission.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility assessment
Timepoint [1] 0 0
Screening to Admission Day 1
Secondary outcome [1] 0 0
Length of stay in the inpatient withdrawal unit
Timepoint [1] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [2] 0 0
Methamphetamine withdrawal symptom severity
Timepoint [2] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [3] 0 0
Methamphetamine craving
Timepoint [3] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [4] 0 0
Sleep dysfunction
Timepoint [4] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [5] 0 0
Mood disturbance
Timepoint [5] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [6] 0 0
Methamphetamine relapse
Timepoint [6] 0 0
1-month post-discharge
Secondary outcome [7] 0 0
Treatment engagement
Timepoint [7] 0 0
1-month post-discharge
Secondary outcome [8] 0 0
Therapeutic alliance
Timepoint [8] 0 0
1-month post-discharge
Secondary outcome [9] 0 0
Incidence of adverse events
Timepoint [9] 0 0
Day 1 of admission to 1-month post-discharge
Secondary outcome [10] 0 0
Perceived burden of intranasal oxytocin
Timepoint [10] 0 0
Admission Day 1 to Admission Day 7
Secondary outcome [11] 0 0
Perceived satisfaction with intranasal oxytocin
Timepoint [11] 0 0
Admission Day 3 and 7
Secondary outcome [12] 0 0
Severity of Clinical Condition
Timepoint [12] 0 0
Baseline to 1-month post-discharge
Secondary outcome [13] 0 0
Improvement of Clinical Condition
Timepoint [13] 0 0
1-month post-discharge

Eligibility
Key inclusion criteria
* Adult females (sex assigned at birth) aged =18 to =65 years, admitted to the Turning Point Addiction Medicine Unit.
* Meeting DSM-5 criteria for Methamphetamine Use Disorder, moderate or severe (assessed by treating physician on pre-admission to residential withdrawal).
* Able to comply with study protocols.
* Able to provide informed consent to participate.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-English-speaking women.
* Women lactating, pregnant or of childbearing potential who are not willing to use an effective means of contraception for the duration of the trial.
* Meeting DSM-5 criteria for moderate-severe substance use disorder other than methamphetamine, nicotine and cannabis, as assessed by treating physician on pre-admission to residential withdrawal.
* Clinically significant or unmanaged medical or psychiatric illness (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder, history of DSM-5 psychotic or bipolar disorder, current severe major depression, current suicidal ideation), assessed by treating physician on pre-admission to residential withdrawal.
* Current participation in another trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
10
Accrual to date
Final
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
National Centre for Clinical Research on Emerging Drugs (NCCRED)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash 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
Shalini Arunogiri
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
Shalini Arunogiri
Address 0 0
Country 0 0
Phone 0 0
+61 3 8413 8413
Fax 0 0
Email 0 0
shalini.arunogiri@easternhealth.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT05760807