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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
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Scientific title
An Open Label Pilot Study of Intranasal Oxytocin for Methamphetamine Withdrawal in Women
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Secondary ID [1]
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NCR3SF18
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Secondary ID [2]
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E21-014-75603
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Universal Trial Number (UTN)
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Trial acronym
mOXY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility assessment
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Assessment method [1]
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Feasibility assessment, as measured by the proportion of screen failures compared to those who received the study drug.
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Timepoint [1]
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Screening to Admission Day 1
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Secondary outcome [1]
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Length of stay in the inpatient withdrawal unit
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Assessment method [1]
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Medical chart review to determine number of days stayed in the inpatient withdrawal unit.
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Timepoint [1]
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Admission Day 1 to Admission Day 7
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Secondary outcome [2]
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Methamphetamine withdrawal symptom severity
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Assessment method [2]
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Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Amphetamine Withdrawal Questionnaire (scores on this measure range from 0 to 40 with higher score indicating greater severity).
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Timepoint [2]
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Admission Day 1 to Admission Day 7
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Secondary outcome [3]
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Methamphetamine craving
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Assessment method [3]
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Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Visual Analogue Scale for Craving (scores on this measure range from 0 to 100, with higher scores indicating greater craving).
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Timepoint [3]
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Admission Day 1 to Admission Day 7
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Secondary outcome [4]
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Sleep dysfunction
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Assessment method [4]
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Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Insomnia Severity Index (scores on this measure range from 0 to 28, with higher scores indicating greater sleep dysfunction).
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Timepoint [4]
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Admission Day 1 to Admission Day 7
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Secondary outcome [5]
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Mood disturbance
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Assessment method [5]
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Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Abbreviated Profile of Mood States - Revised Version (total mood disturbance scores on this measure range from 0 to 116, with higher scores indicating greater disturbance)
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Timepoint [5]
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Admission Day 1 to Admission Day 7
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Secondary outcome [6]
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Methamphetamine relapse
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Assessment method [6]
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Relapse is defined as a yes/no result for any methamphetamine use in the month following discharge from the withdrawal unit, as assessed using the Timeline Follow Back measure.
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Timepoint [6]
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1-month post-discharge
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Secondary outcome [7]
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Treatment engagement
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Assessment method [7]
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Yes/No attendance at any form of treatment to assess treatment engagement at 1-month post-discharge.
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Timepoint [7]
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1-month post-discharge
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Secondary outcome [8]
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Therapeutic alliance
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Assessment method [8]
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Working Alliance Inventory-Short Form Revised will be used to assess therapeutic alliance with nominated primary provider (scores on this measure range from 12 to 60, with higher scores indicating better therapeutic alliance).
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Timepoint [8]
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1-month post-discharge
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Secondary outcome [9]
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Incidence of adverse events
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Assessment method [9]
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Number and categorisation of reported adverse events.
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Timepoint [9]
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Day 1 of admission to 1-month post-discharge
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Secondary outcome [10]
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Perceived burden of intranasal oxytocin
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Assessment method [10]
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Individual average score across the participants' length of stay in the inpatient withdrawal unit on the Visual Analogue Scale for Medication Utilisation Burden (scores on this measure range from 0 to 100, with higher scores indicating greater perceived burden).
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Timepoint [10]
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Admission Day 1 to Admission Day 7
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Secondary outcome [11]
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Perceived satisfaction with intranasal oxytocin
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Assessment method [11]
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Satisfaction with medication based on results from the Treatment Satisfaction Questionnaire (scores on this measure range from 0 to 100, with higher scores indicating greater satisfaction).
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Timepoint [11]
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Admission Day 3 and 7
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Secondary outcome [12]
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Severity of Clinical Condition
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Assessment method [12]
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Change in clinician-rated assessment of the participant's condition using the Clinical Global Impression - Severity Scale (scores on this measure range from 1 to 7, with higher scores indicating poorer condition).
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Timepoint [12]
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Baseline to 1-month post-discharge
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Secondary outcome [13]
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Improvement of Clinical Condition
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Assessment method [13]
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Clinician-rated assessment of the participant's overall clinical condition, substance use, and related problems compared to a baseline assessment, using the Clinical Global Impression - Improvement Scale (scores on this measure range from 5 to 35, with higher scores indicating a worsening of condition in comparison to baseline).
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Timepoint [13]
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1-month post-discharge
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Turning Point - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Funding & Sponsors
Primary sponsor type
Other
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Name
Turning Point
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Centre for Clinical Research on Emerging Drugs (NCCRED)
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Eastern Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Monash University
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
Methamphetamine use disorder (MUD) is a significant public health concern with burden to individuals, families and health systems estimated to cost over $5 billion annually in Australia. In 2016/17 there were 49,670 Australian treatment episodes for MUD, the first step of which typically involves inpatient withdrawal. Currently there are no approved medications to help manage methamphetamine withdrawal and consequently many people drop out of treatment prematurely, leaving them vulnerable to relapse. Oxytocin is a candidate medication that has the potential to increase treatment retention, reduce withdrawal syndrome severity, increase post-withdrawal treatment engagement and reduce relapse rates. The aim of this pilot study is to investigate whether intranasal oxytocin can improve withdrawal treatment outcomes in adult women with MUD. The study will examine the feasibility of intranasal oxytocin as a treatment for methamphetamine withdrawal in women. This will be explored by assessing length of stay in residential withdrawal, withdrawal symptom severity, post-discharge treatment engagement and relapse rates in a group of women who are prescribed intranasal oxytocin during their medically supervised methamphetamine withdrawal at a residential detoxification program. The safety of intranasal oxytocin will also be assessed. A secondary objective of the study is to conduct an exploratory analysis regarding participants' capacity to interact effectively with others, as well as changes in social networks and/or engagement with therapeutic services. There is an observational sub-study affiliated with this main pilot study that is optional for individuals recruited to the main pilot trial to additionally participate in. This sub-study aims to investigate how sleep quality and patterns change before, during, and after detoxification from methamphetamine in women. MUD and sleep disturbances have a complex bidirectional relationship. The use of methamphetamine is known to disrupt sleep quality and the circadian rhythm, although withdrawal from methamphetamine also induces significant sleep-wake cycle changes. There is evidence that methamphetamine disrupts functions regulated by the circadian rhythm. Furthermore, disruptions in circadian rhythms, including mutations in key genes, increases the propensity for addiction. Evaluation of how chronic methamphetamine use may disrupt rhythmicity, and vice versa, may provide invaluable information with regard to potential treatment options of methamphetamine use disorder. There has been little focus, so far, on the therapeutic potential of circadian rhythm modifiers as treatment options in the addiction space, as sleep disturbances have often been merely viewed as a consequence of substance use. Specific to the sub-study, participants will be asked to wear an actigraphy watch. The actigraphy watch device will be worn for at least 7 days prior to, 7 days during, and 7 days post methamphetamine detoxification. This is the only difference between the sub-study and the main pilot study; there are no other additional requirements or assessments involved in the actigraphy sub-study.
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Trial website
https://clinicaltrials.gov/study/NCT05760807
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shalini Arunogiri
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Address
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Turning Point, Eastern Health, Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shalini Arunogiri
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Address
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Country
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Phone
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+61 3 8413 8413
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Fax
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Email
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[email protected]
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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
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