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Inclusion Criteria:

• Male participants:

* with female partner(s) of childbearing potential (including breastfeeding partner) must be willing to use a reliable method of contraception throughout the study period for 30 days) after final investigational medicinal product (IMP) administration for Part 1a, and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
* must not donate sperm starting at screening and throughout the study period and for 30 days) after final IMP administration for Part 1a and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
* with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 5 drug elimination half-lives after final IMP administration.

Part 1

* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusive.
* Body weight of within 50 kg to 100 kg, inclusive.
* Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first drug administration).

Part 2

* BMI within the range of ≥ 18 and ≤ 35 kg/m2 at the screening visit.
* Participant has a diagnosis of moderate to severe OUD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) using the Mini International Neuropsychiatric Interview (MINI) version 7.02.
* Participant is voluntarily seeking treatment for OUD.
* Participant is not currently receiving Medication for Opioid Use Disorder (MOUD), and has not received MOUD within 60 days prior to screening and is:

  * Willing to initiate buprenorphine therapy;
  * Considered to be a good candidate for buprenorphine treatment based on medical and psychosocial history;
  * Has a positive urine drug screen at the initial screening visit and Day -1 for opioids. These may include morphine and metabolites, diacetylmorphine (heroin), codeine, oxycodone, hydrocodone, hydromorphone, fentanyl and metabolites, propoxyphene or oxymorphone.
* Female participants:

  * must not donate ova starting at screening and throughout the study period and 5 drug elimination half-lives after final IMP administration.
  * must not be planning to become pregnant during the study and at least one of the following conditions apply:

    * Woman of non-childbearing potential (WONCBP) and/or
    * Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent until at least for 5 drug elimination half-lives after final IMP administration.

Exclusion Criteria:

* Participant has a history of attempted suicide or suicidal behavior within 12 months prior to screening or has any suicidal ideation that meets criteria at a level of 4 or 5 by using the Columbia Suicide Severity Rating Scale (C-SSRS) within 12 months prior to Screening or who is at significant risk to commit suicide, as assessed at Screening and at Day -1.
* Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system or who are undergoing treatment or evaluation for infertility.
* Females who are lactating or pregnant according to the pregnancy test at Screening or prior to the first study intervention administration.
* A family history of long QT syndrome.
* Any abnormal or clinically significant findings in laboratory test results at Screening.
* Participant has HIV per screening serology test.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG.
* History of significant allergy/ hypersensitivity to AZD4041 or to products related to AZD4041 or other study drugs (including excipients of the formulation), as well as history of severe allergy/hypersensitivity reactions (like angioedema) to any drugs.
* Any vaccination (including with COVID-19 vaccine) less than 14 days prior to first study intervention administration.
* Participants who have a history of exposure to psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) within the last 3 months.

Part 1 Only:

* Past medical history of any clinically significant systemic illness including (but not necessarily limited to) cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, hepatic, endocrinologic, metabolic, genito-urinary, musculoskeletal, immunologic, dermatologic, renal and/or major disease.
* Maintenance therapy with any drug for long-term chronic conditions or significant history of drug dependency or alcohol abuse (\> 21 units/week or \> 3 units/day for men; \> 14 units/week or \> 2 units/day for women; intake of excessive alcohol, acute or chronic).
* History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical manual of Mental Disorders, 5th Edition (American Psychiatric Association 2013).
* History of any substance use disorder (as per DSM-5 criteria).
* Any clinically significant, medical/surgical procedure or trauma within the 28 days prior to the first study intervention administration.
* Positive urine test result for drugs of abuse or cotinine (nicotine), at Screening or prior to the first study intervention administration
* Positive screening results to hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) tests.
* Use of any prescription drugs, including hormone replacement therapy in the 28 days prior to the first study intervention administration.
* Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by an Investigator.
* Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study intervention administration.
* Participants who have medical dietary restrictions.
* Participants with a known hypersensitivity to itraconazole (Part 1a only).

Part 2 Only:

* Participant with clinically significant and uncontrolled cardiovascular, gastrointestinal, pulmonary, hematological, neurological, hepatic, endocrinal, metabolic, musculoskeletal, immunologic, dermatologic, renal and/or any other major disease.
* Participants with a history of severe respiratory insufficiency, obstructive sleep apnea not controlled by a continuous positive airway pressure device or narcolepsy or current clinically significant infections.
* Current diagnosis of chronic pain and who require treatment with opioids.
* Participant has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years of screening.
* Participant has a history of respiratory depression while on buprenorphine-based or other MOUD.
* Participants with active signs or symptoms of hepatitis and requiring treatment; or known or suspected chronic liver disease, including cirrhosis or significant liver fibrosis.
* Participants with current HCV infection.
* Hepatitis B Virus (HBV) infection: Participants with positive hepatitis B surface antigen (HbsAg) or those with a history of Hepatitis B viral infection.
* Participant has known kidney disease and a glomerular filtration rate (GFR) \< 60 mL/min/m2 at screening.
* Participant has comorbid major psychiatric disorders specifically schizophrenia, bipolar disorder or severe major depressive disorder.
* Moderate to severe substance use disorder on any other psychoactive substances (by DSM 5) other than opioids, caffeine or nicotine (eg, alcohol, sedatives).
* If a participant is currently diagnosed with abuse of or dependence on alcohol, the participant will not be allowed to enrol in the study, unless the alcohol abuse/dependence is in full (complete, not partial), sustained (\> 1 year) remission.
* Participants who need to be on prescription central nervous system (CNS) depressant medications including benzodiazepines, during the trial (other than the study interventions).
* Participant has a positive urine drug screen (UDS) results for barbiturates or benzodiazepines at screening or Day -1.
* Participant has a positive urine test for buprenorphine on Day -1.
* Participants with a known hypersensitivity to buprenorphine, naloxone, other opioids or any components of the formulations used.

• Baltimore, Maryland, United States