Methamphetamine Use DisordermOXYNCT05760807
Intranasal Oxytocin for Methamphetamine Withdrawal in Women
A study testing Oxytocin nasal spray in people with Methamphetamine Use Disorder, run by Turning Point at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Mar 2023to 28 Mar 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Pilot Study of Intranasal Oxytocin for Methamphetamine Withdrawal in Women
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.
Read more
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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Oxytocin nasal spray
- Keywords
- Methamphetamine Use Disorder, Intranasal oxytocin, Actigraphy, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Intranasal oxytocin, administered dose 24 international units (IU) twice daily, delivered over 7 days of a residential inpatient withdrawal admission.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal oxytocin | Experimental | 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. Receives: Drug: Oxytocin nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment
Feasibility, operationalised as the proportion of all screened participants who were ineligible before enrolment, with ≤20% indicating feasibility.
Measured: Screening to Admission Day 1
Secondary outcomes (13)
Length of stay in the inpatient withdrawal unit
Medical chart review to determine number of days stayed in the inpatient withdrawal unit.
Measured: Admission Day 1 to Admission Day 7
Methamphetamine withdrawal symptom severity
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).
Measured: Admission Day 1 to Admission Day 7
Methamphetamine craving
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).
Measured: Admission Day 1 to Admission Day 7
Sleep dysfunction
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).
Measured: Admission Day 1 to Admission Day 7
Mood disturbance
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)
Measured: Admission Day 1 to Admission Day 7
Methamphetamine relapse
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.
Measured: 1-month post-discharge
Treatment engagement
Yes/No attendance at any form of treatment to assess treatment engagement at 1-month post-discharge.
Measured: 1-month post-discharge
Therapeutic alliance
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).
Measured: 1-month post-discharge
Incidence of adverse events
Number and categorisation of reported adverse events.
Measured: Day 1 of admission to 1-month post-discharge
Perceived burden of intranasal oxytocin
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).
Measured: Admission Day 1 to Admission Day 7
Perceived satisfaction with intranasal oxytocin
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).
Measured: Admission Day 3 and 7
Severity of Clinical Condition
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).
Measured: Baseline to 1-month post-discharge
Improvement of Clinical Condition
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).
Measured: 1-month post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start29 Mar 2023
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point
- Sponsor type
- University, hospital or other
- Collaborators
- National Centre for Clinical Research on Emerging Drugs (NCCRED), Eastern Health, Monash University
- Responsible party
- Sponsor
- Investigators
- Shalini Arunogiri, Principal investigator, Turning Point, Eastern Health, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760807
- Sponsor's protocol ID
- E21-014-75603
- Other IDs
- NCR3SF18
- Acronym
- mOXY
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of Intranasal Oxytocin for Methamphetamine Withdrawal in Women
- ClinicalTrials.gov ID
- NCT05760807
- Acronym / sponsor ID
- mOXY / E21-014-75603
- Conditions
- Methamphetamine Use Disorder
- Keywords
- Methamphetamine Use Disorder, Intranasal oxytocin, Actigraphy, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turning PointUniversity, hospital or other
- Collaborators
- National Centre for Clinical Research on Emerging Drugs (NCCRED), Eastern Health, Monash University
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 8 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal oxytocin | Experimental | Drug: Oxytocin nasal sprayParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Oxytocin nasal sprayIntranasal oxytocin, administered dose 24 international units (IU) twice daily, delivered over 7 days of a residential inpatient withdrawal admission. | Drug | Intranasal oxytocin |
Primary outcome
Feasibility assessment
Time frame: Screening to Admission Day 1
Feasibility, operationalised as the proportion of all screened participants who were ineligible before enrolment, with ≤20% indicating feasibility.
13 secondary outcomes
Length of stay in the inpatient withdrawal unit
Time frame: Admission Day 1 to Admission Day 7
Methamphetamine withdrawal symptom severity
Time frame: Admission Day 1 to Admission Day 7
Methamphetamine craving
Time frame: Admission Day 1 to Admission Day 7
Sleep dysfunction
Time frame: Admission Day 1 to Admission Day 7
Mood disturbance
Time frame: Admission Day 1 to Admission Day 7
Methamphetamine relapse
Time frame: 1-month post-discharge
Treatment engagement
Time frame: 1-month post-discharge
Therapeutic alliance
Time frame: 1-month post-discharge
Incidence of adverse events
Time frame: Day 1 of admission to 1-month post-discharge
Perceived burden of intranasal oxytocin
Time frame: Admission Day 1 to Admission Day 7
Perceived satisfaction with intranasal oxytocin
Time frame: Admission Day 3 and 7
Severity of Clinical Condition
Time frame: Baseline to 1-month post-discharge
Improvement of Clinical Condition
Time frame: 1-month post-discharge
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 6 Oct 2026.
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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.
Shalini Arunogiri 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 Oxytocin nasal spray 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 4 inclusion and 5 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 6 Oct 2026. 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?
Feasibility assessment (time frame: Screening to Admission Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.