Alcohol Use Disorder (AUD)Phase 3AUDNCT07433413
Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder
A Phase 3 study testing Naltrexone in people with Alcohol Use Disorder (AUD), run by Shenzhen Sciencare Medical Industries Co., Ltd..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD). After providing written informed consent and undergoing screening for eligibility criteria, eligible subjects will be randomized in a 2:1 ratio to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 1 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe Alcohol Use Disorder (AUD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (meeting four or more diagnostic criteria; refer to Appendix 1 for details).
Who cannot join
- Pregnant, breastfeeding, or pregnant with a positive pregnancy test at screening. This includes women of childbearing potential planning to become pregnant during the study.
- Note: Women of childbearing potential are defined as those who are biologically capable of becoming pregnant. To be considered not of childbearing potential, a female subject must meet one of the following: 1) Have had a hysterectomy or bilateral oophorectomy; or 2) Be post-menopausal, defined as having no menses for more than 12 consecutive months.
- Significant abnormality in liver function (e.g., AST or ALT > 3 times the upper limit of normal), liver failure (e.g., presence of ascites, jaundice, coagulopathy, hepatorenal syndrome, or hepatic encephalopathy), or liver/gallbladder ultrasound findings that may significantly impact the assessment of the investigational drug's efficacy and safety.
- History of severe pancreatitis or severe delirium tremens. Presence of any severe/uncontrolled systemic diseases (e.g., respiratory, cardiovascular, gastrointestinal, neurological, hematological, urogenital, or endocrine disorders) or psychiatric disorders (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder) or other major illnesses, which in the Investigator's judgment could interfere with the provision of informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise affect the achievement of study objectives.
- Potential need for hospitalization or surgery during the study period, including scheduled elective surgeries that cannot be postponed.
- Diagnosis of a Substance Use Disorder (other than alcohol or tobacco) based on DSM-5 criteria within the past year (prior to randomization/dosing), such as benzodiazepines, amphetamines, opioids, or cocaine.
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- Use of anti-relapse medication (e.g., Naltrexone) or receipt of systemic psychological support therapy within 30 days prior to randomization/dosing.
- Currently receiving treatment for substance use disorders (e.g., opioids, amphetamines, alcohol), or received opioids within 7 days prior to randomization/dosing, or may require opioid treatment during the study; or positive urine drug screen for opioids, cannabis, amphetamines, etc., or positive naloxone challenge test on the day of randomization/dosing.
- Suicidal risk based on Investigator's clinical judgment, or history of suicidal or self-mutilating behavior.
- Allergy to the investigational product or its excipients (polylactic acid, magnesium stearate) or local anesthetics.
- Currently participating in any investigational drug or device study, or has used any investigational drug or device within 30 days prior to randomization/dosing.
- Skin infection at the implantation site, systemic skin disease, or keloid scarring that may affect the assessment of the investigational drug's efficacy and safety.
- Clinical or laboratory evidence of Human Immunodeficiency Virus (HIV) or Syphilis infection.
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Naltrexone Hydrochloride Implant for the Treatment of Alcohol Use Disorder
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial.
The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD). After providing written informed consent and undergoing screening for eligibility criteria, eligible subjects will be randomized in a 2:1 ratio to receive treatment in either the experimental group (1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy) or the control group (placebo implant plus non-specific supportive psychotherapy).
Read more
On Day 1, subjects will receive a single subcutaneous implantation via a small abdominal incision, receiving either the Naltrexone Hydrochloride Implant or the placebo implant. Following implantation, subjects will be hospitalized for at least 2 hours (the investigator may extend this observation period up to 3 days based on the patient's condition). Subjects will change the wound dressing by themselves on postoperative Day 3.
Efficacy and safety assessments will continue through Week 24 post-randomization/dosing, involving a total of 11 visits. Among these, Visit 5 (Week 3) will be conducted via telephone, while all other visits will be performed as outpatient clinic visits.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Naltrexone, placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration
placeboDrug
Dosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects in the experimental group will receive the 1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy. Receives: Drug: Naltrexone |
| Control Group | Placebo comparator | Placebo Implant plus non-specific supportive psychotherapy Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Heavy Drinking Days During the 24-Week Observation Period Post-Randomization/Post-Dosing
Specifically, this is calculated as the number of heavy drinking days divided by the number of days at risk for heavy drinking, with the aforementioned days counted up to the date of discontinuation of efficacy observation.
"Days at risk for heavy drinking" are defined as the number of days a subject is under efficacy observation starting from the date of hospital discharge following implant administration.
Drinking rates are assessed based on the Timeline Follow-Back (TLFB) method, utilizing the daily drinking record form (Appendix 11) completed by the subject and their family members. Heavy drinking is defined as consumption of ≥5 standard drinks per day for males and ≥4 standard drinks per day for females.
Measured: 24-Week
Secondary outcomes (11)
Reduction of ≥2 levels in WHO alcohol risk grading
Specifically, this refers to the change from the baseline WHO alcohol risk level to the level assessed during weeks 21-24.
The baseline WHO alcohol risk level is calculated based on TLFB alcohol consumption data collected during the 2-week period prior to detoxification.
The WHO alcohol risk level assessed at weeks 21-24 post-randomization/post-dosing is calculated based on the daily drinking record form completed by the subject and their family members.
Measured: 24-week
Alcohol Consumption (Total Amount Consumed Over 24 Weeks)
Calculated based on the daily drinking record form (completed by the subject and their family members) using the Timeline Follow-Back (TLFB) method.
Measured: 24-week
Percentage of Days Abstinent (PDA)
Specifically, this is calculated as the number of days with no alcohol consumption divided by the number of days at risk. The aforementioned days are counted up to the date of discontinuation of efficacy observation.
"Days at risk" are defined as the number of days a subject is under efficacy observation, starting from the date of hospital discharge following implant administration.
This metric is calculated based on the drinking record form using the Timeline Follow-Back (TLFB) method. Alcohol consumption is defined as any recorded drinking behavior, regardless of the amount or frequency consumed.
Measured: 24-week
Longest Continuous Abstinence Duration
Specifically, this refers to the longest consecutive number of days without alcohol consumption from the time of randomization/dosing until loss to follow-up or study completion. This metric is calculated based on the daily drinking record form (completed by the subject and their family members) using the Timeline Follow-Back (TLFB) method.
Measured: 24-week
Proportion of Participants Without Heavy Drinking During the Study Observation Period
Specifically, this refers to the proportion of subjects who did not engage in heavy drinking from randomization/dosing until loss to follow-up or study completion. This metric is calculated based on the daily drinking record form (completed by the subject and their family members) using the Timeline Follow-Back (TLFB) method.
Measured: 24-week
Alcohol Craving Score
Craving scores are assessed at 1, 2, 4, 8, 12, 16, 20, and 24 weeks post-randomization/post-dosing using a Visual Analog Scale (VAS).
VAS Assessment:
The VAS consists of a horizontal line. The left end is marked as "0," indicating "No craving," and the right end is marked as "10," indicating "Extreme craving." The intermediate sections represent varying degrees of craving.
Subjects are asked to self-evaluate and select a numerical value between 0 and 10 that best represents their current level of craving. A higher numerical value indicates a higher degree of craving.
Measured: 24-week
Personal and Social Functioning
Assessment of personal and social functioning at 4, 8, 12, 16, 20, and 24 weeks post-randomization/post-dosing using the Personal and Social Performance scale (PSP).
PSP Total Score Rating Guidelines 71-100: These ratings reflect mild difficulties. 31-70: These ratings reflect various degrees of functional impairment. 0-30: These ratings reflect functional disability, indicating that the patient requires active support or close supervision
Measured: 24-week
Pleasure Scale Score (Snaith-Hamilton Pleasure Scale, SHAPS)
Assessment of the level of agreement regarding pleasure responses in various enjoyable situations at 4, 8, 12, 16, 20, and 24 weeks post-randomization/post-dosing. This is evaluated using the Snaith-Hamilton Pleasure Scale (SHAPS).
Measured: 24-week
Family APGAR Questionnaire
A qualitative assessment of family members' satisfaction regarding five basic family functions at 4, 8, 12, 16, 20, and 24 weeks post-randomization/post-dosing. This assessment is conducted using the Family APGAR Questionnaire.
Measured: 24-week
Breath Alcohol Concentration (BrAC)
Measurement of breath alcohol concentration at 1, 2, 4, 8, 12, 16, 20, and 24 weeks post-randomization/post-dosing using a digital breath alcohol tester.
Measured: 24-week
Proportion of Participants Requiring Hospitalization for Detoxification
Specifically, this refers to the proportion of subjects who required hospitalization for alcohol detoxification following randomization/dosing.
Measured: 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433413
- Sponsor's protocol ID
- SK2007-NQT-301
- Acronym
- AUD
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Naltrexone Hydrochloride Implant for the Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07433413
- Acronym / sponsor ID
- AUD / SK2007-NQT-301
- Conditions
- Alcohol Use Disorder (AUD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 Feb 2026 (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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial.
The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD). After providing written informed consent and undergoing screening for eligibility criteria, eligible subjects will be randomized in a 2:1 ratio to receive treatment in either the experimental group (1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy) or the control group (placebo implant plus non-specific supportive psychotherapy).
On Day 1, subjects will receive a single subcutaneous implantation via a small abdominal incision, receiving either the Naltrexone Hydrochloride Implant or the placebo implant. Following implantation, subjects will be hospitalized for at least 2 hours (the investigator may extend this observation period up to 3 days based on the patient's condition). Subjects will change the wound dressing by themselves on postoperative Day 3.
Efficacy and safety assessments will continue through Week 24 post-randomization/dosing, involving a total of 11 visits. Among these, Visit 5 (Week 3) will be conducted via telephone, while all other visits will be performed as outpatient clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: NaltrexoneSubjects in the experimental group will receive the 1.5 g Naltrexone Hydrochloride Implant plus non-specific supportive psychotherapy. |
| Control Group | Placebo comparator | Drug: placeboPlacebo Implant plus non-specific supportive psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of moderate to severe Alcohol Use Disorder (AUD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (meeting four or more diagnostic criteria; refer to Appendix 1 for details).
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding, or pregnant with a positive pregnancy test at screening. This includes women of childbearing potential planning to become pregnant during the study.
- Note: Women of childbearing potential are defined as those who are biologically capable of becoming pregnant. To be considered not of childbearing potential, a female subject must meet one of the following: 1) Have had a hysterectomy or bilateral oophorectomy; or 2) Be post-menopausal, defined as having no menses for more than 12 consecutive months.
- Significant abnormality in liver function (e.g., AST or ALT > 3 times the upper limit of normal), liver failure (e.g., presence of ascites, jaundice, coagulopathy, hepatorenal syndrome, or hepatic encephalopathy), or liver/gallbladder ultrasound findings that may significantly impact the assessment of the investigational drug's efficacy and safety.
- History of severe pancreatitis or severe delirium tremens. Presence of any severe/uncontrolled systemic diseases (e.g., respiratory, cardiovascular, gastrointestinal, neurological, hematological, urogenital, or endocrine disorders) or psychiatric disorders (e.g., Major Depressive Disorder, Schizophrenia, Bipolar Disorder) or other major illnesses, which in the Investigator's judgment could interfere with the provision of informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise affect the achievement of study objectives.
- Potential need for hospitalization or surgery during the study period, including scheduled elective surgeries that cannot be postponed.
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 |
|---|---|---|
| NaltrexoneDosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration | Drug | Experimental Group |
| placeboDosage Form: Implant Specification: 150 mg/Tablet Dosage and Administration: Subcutaneous implantation of 10 tablets (1500 mg) Duration of Treatment: Single administration | Drug | Control Group |
Primary outcome
Proportion of Heavy Drinking Days During the 24-Week Observation Period Post-Randomization/Post-Dosing
Time frame: 24-Week
Specifically, this is calculated as the number of heavy drinking days divided by the number of days at risk for heavy drinking, with the aforementioned days counted up to the date of discontinuation of efficacy observation. "Days at risk for heavy drinking" are defined as the number of days a subject is under efficacy observation starting from the date of hospital discharge following implant administration. Drinking rates are assessed based on the Timeline Follow-Back (TLFB) method, utilizing the daily drinking record form (Appendix 11) completed by the subject and their family members. Heavy drinking is defined as consumption of ≥5 standard drinks per day for males and ≥4 standard drinks per day for females.
11 secondary outcomes
Reduction of ≥2 levels in WHO alcohol risk grading
Time frame: 24-week
Alcohol Consumption (Total Amount Consumed Over 24 Weeks)
Time frame: 24-week
Percentage of Days Abstinent (PDA)
Time frame: 24-week
Longest Continuous Abstinence Duration
Time frame: 24-week
Proportion of Participants Without Heavy Drinking During the Study Observation Period
Time frame: 24-week
Alcohol Craving Score
Time frame: 24-week
Personal and Social Functioning
Time frame: 24-week
Pleasure Scale Score (Snaith-Hamilton Pleasure Scale, SHAPS)
Time frame: 24-week
Family APGAR Questionnaire
Time frame: 24-week
Breath Alcohol Concentration (BrAC)
Time frame: 24-week
Proportion of Participants Requiring Hospitalization for Detoxification
Time frame: 24-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone in people with Alcohol Use Disorder (AUD), run by Shenzhen Sciencare Medical Industries Co., Ltd..
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 1 inclusion and 13 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: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of Heavy Drinking Days During the 24-Week Observation Period Post-Randomization/Post-Dosing (time frame: 24-Week). 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 25 Feb 2026.