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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
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.
Trial website
https://clinicaltrials.gov/study/NCT05760807
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05760807