Study of daridorexant and buprenorphine combination treatment for patients with opioid use disorder

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What is this study about?

This clinical trial focuses on treating patients with Opioid Use Disorder (OUD), a condition where a person becomes dependent on opioid substances. The study will test whether adding daridorexant, a sleep medication, can help improve the effectiveness of standard OUD treatment with buprenorphine. Buprenorphine is a medication commonly used to treat opioid dependence.

The study aims to determine if daridorexant can help reduce the use of illegal substances in patients who are receiving buprenorphine treatment. During the study, participants will receive either daridorexant or placebo while continuing their regular buprenorphine treatment. The buprenorphine will be given as an injection under the skin or as tablets that dissolve under the tongue.

The treatment period will last for several months, during which participants will regularly provide urine samples and complete questionnaires about their sleep quality, drug cravings, and overall well-being. The study will monitor how well participants respond to the combined treatment approach and whether it helps them maintain their recovery from opioid use disorder.

1 Initial assessment and medication start

After confirming your eligibility and obtaining your consent, you will start receiving buprenorphine treatment.

If you are not currently on buprenorphine treatment, you will first be stabilized using sublingual tablets (placed under the tongue).

Once stabilized, you will receive depot buprenorphine through subcutaneous injection (under the skin).

2 Study medication phase

You will receive either daridorexant tablets or placebo tablets to take by mouth.

The study will last for 13 weeks.

You will need to take the assigned medication as prescribed throughout the study period.

3 Weekly assessments

Each week, you will need to provide a urine sample for testing.

You will complete several questionnaires about:

– Your cravings for opioids

– Any withdrawal symptoms you may experience

– Your sleep quality

You will report your substance use through a timeline follow-back method.

4 Monthly assessments

Once per month, you will complete additional questionnaires about:

– The severity of substance-related issues

– Your sleep problems

– Your daily functioning and activities

5 Study completion

The study will conclude after the 13-week period.

Your participation will help evaluate if daridorexant can reduce substance use when added to buprenorphine treatment.

Who Can Join the Study?

Age between 20 and 65 years old (men and women)
Must have moderate-to-severe opioid use disorder (a condition involving problematic opioid use) for at least 1 year, confirmed by a healthcare professional
Can be either:
- Currently not in stable recovery from opioid use
- In stable recovery but still using other substances
Eligible if:
- Not currently receiving opioid maintenance treatment
- Currently receiving buprenorphine treatment (a medication used to treat opioid dependence) taken under the tongue or inside the cheek
Must be able to speak and read Swedish
Must be willing to provide informed consent (agreement to participate after understanding study details)

Who Cannot Join the Study?

Current diagnosis of severe mental health conditions (such as schizophrenia, bipolar disorder, or severe depression)
History of seizures or epilepsy
Pregnant women or those planning pregnancy during the study period
Current severe liver disease (problems with liver function)
Use of medications that could interact with the study drug
Participation in another clinical trial within the past 30 days
Unable to follow study procedures or attend scheduled visits
History of allergic reactions to similar medications
Unstable medical conditions that could interfere with the study
Sleep apnea (a condition where breathing repeatedly stops during sleep) that is not properly treated
Current use of other sleep medications that cannot be discontinued
History of substance abuse other than opioids in the past 30 days
Severe breathing problems or respiratory conditions
Inability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Stockholm – SLSO	Stockholm	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Cznuc Hfvjuoacea Aq	Stockholm	Sweden
Uuepccu Unaluzucxn Hkkrtdbs	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Daridorexant is a medication that works by blocking orexin receptors in the brain. It is being studied as a potential treatment to help people who are dealing with opioid use disorder. This medication affects sleep-wake cycles and may help reduce cravings for illicit substances.

Buprenorphine is a well-established medication used to treat opioid dependence. It helps reduce withdrawal symptoms and cravings in people who are recovering from opioid use disorder. In this trial, it is used in a long-acting depot form, which means it is given as an injection that releases the medication slowly over time.

Opioid Use Disorder – A chronic medical condition characterized by a problematic pattern of opioid use that causes significant impairment in daily life. The disorder develops when a person becomes physically and psychologically dependent on opioids, whether prescription pain medications or illegal substances. People with this condition experience strong urges to use opioids and may need increasing amounts to achieve the desired effect. The disorder often involves difficulties controlling opioid use, continued use despite problems in relationships or responsibilities, and the development of tolerance. Physical and emotional changes occur, including sleep disturbances and mood fluctuations when opioids are not taken.

Trial ID:

2024-517482-16-00

Protocol code:

BUDA

Trial Phase:

Therapeutic exploratory (Phase II)

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