The Tina Trial is a clinical trial designed to see whether mirtazapine, an antidepressant medication, can help people reduce their use of methamphetamine (ice, crystal meth). Two previous small trials in the USA found that mirtazapine helped people to reduce their methamphetamine use and improved their mood. We want to find out whether mirtazapine can be used in routine clinical care in Australia.
The trial has been funded by the Medical Research Future Fund and is being conducted by researchers and clinicians across Australia and in the USA. Further information about the team can be found here. The information below is for people interested in participating in the trial and their friends and family.
What is involved in participating?
If you are interested in the trial, we start by assessing whether this trial is right for you. This will involve asking some questions over the phone, and then doing a more comprehensive face-to-face survey and a medical assessment. We may suggest other treatments instead of the trial.
If you enrol in the trial, you will be given the trial medication to take home. You will be asked to take one tablet each evening for 16 weeks. The tablet will contain either mirtazapine or be a placebo (dummy) tablet. You will have a 50% chance (one in two chance) of receiving mirtazapine and a 50% chance of receiving the placebo. You will not know which one you will be taking.
During the trial we will meet with you regularly to monitor your health (these assessments take about 45 minutes each). There are ten assessments all up, and you will be involved in the trial for about five months. The first assessment will be done at your local clinic. After that, we can meet you at a more convenient location and we can also do some assessments by phone or zoom if you prefer. You will be reimbursed for each assessment.
You can continue to receive whatever other treatments you need, provided that they do not compromise your safety or prevent you from participating in the trial assessments. You can also decide to stop the medication if you don’t like it, or withdraw from the study entirely.
If you are interested in participating, please get in touch and we can tell you more about what the trial involves. We will keep all your information confidential.
Frequently asked questions
Why mirtazapine for methamphetamine?
There are currently no approved medications for treating methamphetamine dependence. Mirtazapine is an antidepressant which has been found to help people reduce methamphetamine use and reduce symptoms of depression in people who use methamphetamine. This evidence is based on two small trials conducted in the USA. The aim of the current trial is to extend that evidence to routine clinical care in Australia.
What kind of tests are involved?
You will be asked to do saliva tests during the trial (4 in total) to monitor your methamphetamine use. Women must do a pregnancy test. The trial’s doctor may do other tests to make sure it is safe for you to participate on the trial.
At each assessment you will be asked a variety of questions about your general health, mood, sleep, drug use, HIV risk, and your contact with health services.
Will it cost money?
It is free to participate in the trial. You will be reimbursed $50 for each research assessment.
What about COVID?
Our clinics have rules about COVID that you may need to follow. We can discuss these with you when you enrol in the study. Due to COVID-19 restrictions, some assessments may be done remotely (e.g., telehealth, videoconference or phone).
Why do some people get a placebo?
A placebo is a tablet with no active ingredients. It looks like the real thing but is not. Currently there is not enough evidence to be sure that mirtazapine is safe or effective for treating methamphetamine dependence. By comparing outcomes for people taking mirtazapine with outcomes for people taking a placebo medication, we can find out whether mirtazapine works and whether it causes any side-effects.
Will I know whether I am taking mirtazapine or placebo?
Neither you nor the trial staff will know whether you are receiving mirtazapine or placebo. This information will be made available at the end of the study in 2025.
Who is eligible?
You must be aged 18 to 65 years and dependent on methamphetamine. You must not be pregnant or breastfeeding. You must not be already taking antidepressant medication.
You will need to do a medical assessment to make sure that it is safe for you to take the trial medication. Our trial doctor may suggest other treatment options, instead of the trial, if the medication is not suited to you.
Can I receive other treatments while on the trial?
Once enrolled in the trial, you will be free to access other services and treatments. All of the trial sites offer counselling and other support services for alcohol and other drugs. Some treatments (e.g., certain medications) may put your health at risk. If this is the case, the study team may decide to stop the trial medication.
Where is the trial recruiting?
The trial is recruiting from Wollongong, Geelong, Perth and Brisbane. We are seeking additional sites, particularly outside major metropolitan areas. Please see location options to the right of the screen or visit us on Facebook.
When will the trial start?
The Tina Trial will run over four years (2021 – 2025). Recruitment will start in 2022 and continue until the end of 2024.
Can a friend or partner join the trial?
Anyone can apply to join the trial and will go through the same screening and eligibility procedures.
What if I have a loved one who is addicted to Ice?
Participation in the trial is completely voluntary and each participant must contact us directly to enrol. We cannot take referrals from family, friends, or other health services. There are a range of support services available for friends and family.
What are the risks?
Side-effects from mirtazapine
Mirtazapine has side effects. Most commonly, weight gain and drowsiness. Some people are at risk of mood disturbances and increased risk of suicidality. We will monitor these symptoms during the trial and may suggest other treatment or stopping the trial medication if these problems affect you.
Participation is confidential
All trial data is confidential, however, your participation in the trial will go on your medical record. There are some situations where we have a duty of care or a legal obligation to disclose your personal information (eg, if you are suicidal, or if we receive a court order). These situations are not common.
What happens if something goes wrong?
If you experience any serious health problems while you are on the trial, you will be provided with medical treatment through the trial clinic, or referred to appropriate medical care.
Where else can I get help for ice use?
A number of free and confidential support services are available for people experiencing problems with ice, as well as their family and friends. Call the National Alcohol and Other Drug Hotline on 1800 250 015 to be automatically directed to the Alcohol and Drug Information Service in your state or territory.
For emergency support, call Lifeline on 131 114 or dial '000' for ambulance or police.
Want to know more?
Send us an email at email@example.com
This trial has been approved by the University of Wollongong Human Research Ethics Committee #2021/ETH12037