Alcohol Use DisorderPhase 2NCT04770493
Enhancing the Effects of Alcohol Treatment With Lamotrigine
A Phase 2 study testing Lamotrigine in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
Trial summary
This study will help determine the tolerability and efficacy of the mood-stabilizing anticonvulsant lamotrigine in youth with alcohol use disorder. It will also help establish whether and how lamotrigine improves outcomes related to alcohol use. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 24 Oct 2024
- Phase
- Phase 2
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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16 to 24 years old, inclusive
- Self-reports consuming alcohol ≥ 2 days/week on average in the past 90 days of which ≥ 5 days involved ≥ 4 drinks within a 2-hr period (i.e., binge drinking) for boys and ≥ 3 drinks for girls
- Meet the DSM-5 criteria for alcohol use disorder (AUD)
- Be interested in reducing alcohol use
- Be able to read simple English
- Females taking estrogen-containing oral contraceptives have to agree to use secondary methods of birth control, such as condoms because lamotrigine lowers the effectiveness of estrogen-containing oral contraceptives. Sexually active females cannot be in this study if they do not agree to use a barrier method of birth control (condom) every time they engage in sexual intercourse.
Who cannot join
- Currently receiving formal AUD treatment
- Significant alcohol withdrawal symptoms
- Coexisting moderate or severe substance use disorder other than cannabis and nicotine, as defined by DSM-5 criteria.
- Positive urine toxicology screen any substances other than cannabis (THC)
- Currently taking a pharmacotherapy for AUD, a carbonic anhydrase inhibitor, or a glucuronidation
- Compelled to alcohol treatment by the justice system or has probation or parole requirements that might interfere with study participation
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- History of rash that was serious, required hospitalization, or related to lamotrigine
- Have a history of any serious, unstable medical illness including seizures or hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
- Clinically significant abnormal liver function tests, including elevation of liver enzymes (AST, ALT) 3-fold above the upper limit of normal.
- Abnormal BUN and creatinine for renal impairment
- Renal or hepatic impairment
- Clinically significant abnormalities per physical exam, hematological assessment, bilirubin concentration, or urinalysis
- Pregnant, nursing, or refusing to use a condom, if female.
- Used psychotropic or anticonvulsant medication (prescribed by a health care professional) in the past 30 days (e.g., topiramate)
- Taking medications contraindicated with lamotrigine (e.g., valproate acid [Depakote], carbamazepine, phenytoin, phenobarbital, primidone, and rifampin, protease inhibitors lopinavir/ritonavir and atazanavir/lopinavi
- History of prior treatment with lamotrigine
- Known sensitivity or allergy to lamotrigine
- A previous history of drug reaction with eosinophilia and systemic symptoms (DRESS) or blood dyscrasias
- A history of Steven-Johnson syndrome or any presentation of symptoms suggestive of Steven-Johnson syndrome.
- Current or lifetime history of psychosis or suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903
About this study
Official title: Proof-of-Concept Clinical Trial of Lamotrigine as a Candidate Pharmacotherapy for Adolescent Alcohol Use Disorder
This study will help determine the tolerability and efficacy of the mood-stabilizing anticonvulsant lamotrigine in youth with alcohol use disorder. It will also help establish whether and how lamotrigine improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.
Read the detailed description
Adolescent alcohol use is a leading public health concern worldwide. Clinical trials have tested a variety of psychosocial interventions with youth that yield only modest short-term benefits. One potential way to improve treatments is to augment psychosocial interventions with pharmacotherapy. The National Institutes of Health has mounted a concerted effort to identify medications that reduce drinking for nearly three decades. Although this effort improved treatment for adults, no medication is indicated for adolescent use and randomized controlled trials with teenagers are almost nonexistent. This gap raises key questions about whether and how medications could benefit youth. Optimizing treatment options for youth requires closing this important gap. Lamotrigine is safe with adolescents and does not adversely interact with alcohol. Lamotrigine targets brain mechanisms implicated in alcohol use disorder, and it has shown to help treat adults with alcohol problems. Yet, despite its widespread use with children and adolescents, no published double-blind, placebo-controlled studies have examined the effects of lamotrigine on drinking-related behavior in youth. The purpose of this study is to determine how well teenagers accept lamotrigine plus alcohol education to reduce adolescent alcohol use. This study will also tell us whether teenagers' alcohol use, craving, and enjoyment of drinking are reduced by lamotrigine.
- Conditions
- Alcohol Use Disorder
- Being tested
- Lamotrigine, Placebo
- Keywords
- Alcohol, Teenager, Medication, Clinical Trial
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal
Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills).
PlaceboDrug
Matching placebo (sugar pill)
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | Experimental | Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Receives: Drug: Lamotrigine |
| Placebo | Placebo comparator | Identical matching placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rates
The number and percentage of youth who complete the active medication phase will determine feasibility.
Measured: 9-week active treatment phase
Acceptability of the Study Medication
The Client Satisfaction Questionnaire (CSQ-8) ranges from 8 to 32 (higher scores indicate higher satisfaction) and will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" ranges on the CSQ-8 is equal to or greater than 80%.
Measured: 9-week active treatment phase
Secondary outcomes (1)
Alcohol Craving
The primary measure of alcohol craving will be the following single-item: How strong is your craving to drink alcohol? Scores range from 0 (none) to 20 (extremely strong).
Measured: 9-week active treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start24 Jan 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 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.
- Other trials for Alcohol Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Miranda, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770493
- Sponsor's protocol ID
- 2004002676
- Other IDs
- R21AA028394
- Status last verified
- Dec 2024
- First submitted
- 22 Feb 2021
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per sponsor requirements, all data will be uploaded to the NIAAA Data Repository.