Alcohol Use DisorderPhase 2NCT03707951
N-Acetylcysteine for Adolescent Alcohol Use Disorder
A Phase 2 study testing N-acetylcysteine in people with Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 26 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject is 13-25
- Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).
- Current moderate to heavy drinker by established adolescent criteria
- Meet criteria for alcohol use disorder
- Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring
Who cannot join
- Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol
- Allergy or intolerance to N-acetylcysteine
- Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
- Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
- Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
- Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.
Read the detailed description
Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.
- Conditions
- Alcohol Use Disorder
- Being tested
- N-acetylcysteine, Placebo oral capsule
- Keywords
- alcohol, youth, adolescent, pharmacotherapy, medication, N-acetylcysteine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
Placebo oral capsuleDrug
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
Measured: Final 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start27 Feb 2019
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel group allocation randomized placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Gray, Medical University of South Carolina
- Investigators
- Kevin M Gray, MD, Principal investigator, Professor of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707951
- Sponsor's protocol ID
- PRO#00080921
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2018
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Squeglia LM, Tomko RL, Baker NL, Kirkland AE, McClure EA, Gray KM. A Randomized Controlled Trial of N-acetylcysteine for Adolescent and Young Adult Alcohol Use Disorder. J Am Acad Child Adolesc Psychiatry. 2025 Sep 26:S0890-8567(25)02088-X. doi: 10.1016/j.jaac.2025.09.025. Online ahead of print.
PubMed 41016625
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03707951
- Acronym / sponsor ID
- PRO#00080921
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol, youth, adolescent, pharmacotherapy, medication, N-acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 8 Jan 2025
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 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.
Detailed description
Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 parallel group allocation randomized placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteineN-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subject is 13-25
- Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).
- Current moderate to heavy drinker by established adolescent criteria
- Meet criteria for alcohol use disorder
- Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring
Key exclusion criteria (6 listed)
- Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol
- Allergy or intolerance to N-acetylcysteine
- Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
- Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
- Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
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 |
|---|---|---|
| N-acetylcysteineN-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally) | Drug | N-acetylcysteine |
| Placebo oral capsulePlacebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally) | Drug | Placebo |
Primary outcome
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
Time frame: Final 4 weeks of treatment
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41016625Squeglia LM, Tomko RL, Baker NL, Kirkland AE, McClure EA, Gray KM. A Randomized Controlled Trial of N-acetylcysteine for Adolescent and Young Adult Alcohol Use Disorder. J Am Acad Child Adolesc Psychiatry. 2025 Sep 26:S0890-8567(25)02088-X. doi: 10.1016/j.jaac.2025.09.025. Online ahead of print.
- 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. This study is not recruiting at the moment.
Kevin M Gray, MD principal investigator
Professor of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Alcohol Use Disorder, run by Medical University of South Carolina at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8) (time frame: Final 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707951, which also lists 1 linked publication.
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 8 Jan 2025.