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Enhancing the Effects of Alcohol Treatment With Lamotrigine

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lamotrigine

Placebo

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol, Teenager, Medication, Clinical Trial

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

16 to 19 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.

Exclusion Criteria:

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
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

Sites / Locations

Brown University Center for Alcohol and Addiction StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lamotrigine

Placebo

Arm Description

Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks

Identical matching placebo capsules

Outcomes

Primary Outcome Measures

Completion rates

Percentage of youth who complete the active medication phase will determine feasibility.

Acceptability of the study medication

Study withdrawal and the Client Satisfaction Questionnaire (CSQ-8), which ranges from 8-32 (higher scores indicate higher satisfaction) will determine acceptability

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04770493

First Posted

February 22, 2021

Last Updated

March 21, 2023

Sponsor

Brown University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), Rhode Island Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04770493

Brief Title

Enhancing the Effects of Alcohol Treatment With Lamotrigine

Official Title

Proof-of-Concept Clinical Trial of Lamotrigine as a Candidate Pharmacotherapy for Adolescent Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 24, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Alcohol, Teenager, Medication, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lamotrigine

Arm Type

Experimental

Arm Description

Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Identical matching placebo capsules

Intervention Type

Drug

Intervention Name(s)

Lamotrigine

Other Intervention Name(s)

Lamictal

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo (sugar pill)

Primary Outcome Measure Information:

Title

Completion rates

Description

Percentage of youth who complete the active medication phase will determine feasibility.

Time Frame

9-week active treatment phase

Title

Acceptability of the study medication

Description

Study withdrawal and the Client Satisfaction Questionnaire (CSQ-8), which ranges from 8-32 (higher scores indicate higher satisfaction) will determine acceptability

Time Frame

9-week active treatment phase

Secondary Outcome Measure Information:

Title

Alcohol craving

Description

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).

Time Frame

9-week active treatment phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 16 to 19 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. Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Miranda, PhD

Phone

(401) 863-6658

Robert_Miranda_Jr@brown.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Hayley Treloar Padovano, PhD

Phone

(401) 863-6623

Hayley_Treloar@brown.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Miranda, PhD

Organizational Affiliation

Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brown University Center for Alcohol and Addiction Studies

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Miranda, PhD

Phone

401-863-6658

Robert_Miranda_Jr@brown.edu

First Name & Middle Initial & Last Name & Degree

Brianna Parlette, MS

Phone

401 863-6687

Brianna_Parlette@brown.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Per sponsor requirements, all data will be uploaded to the NIAAA Data Repository.

IPD Sharing Time Frame

One year after the completion of the project.

IPD Sharing Access Criteria

As required by the Sponsor, the data from this clinical trial will be uploaded to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) data repository. Like all NIAAA grants, the NIAAA will govern the access criteria.

Learn more about this trial

Enhancing the Effects of Alcohol Treatment With Lamotrigine

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