Trial Outcomes & Findings for Enhancing the Effects of Alcohol Treatment With Lamotrigine (NCT NCT04770493)

NCT ID: NCT04770493

Last Updated: 2025-06-13

Results Overview

The number and percentage of youth who complete the active medication phase will determine feasibility.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

9-week active treatment phase

Results posted on

2025-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lamotrigine Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Overall Study STARTED	23	21
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing the Effects of Alcohol Treatment With Lamotrigine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine n=23 Participants Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo n=21 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)	Total n=44 Participants Total of all reporting groups
Age, Continuous	19.61 years STANDARD_DEVIATION 1.34 • n=93 Participants	20.33 years STANDARD_DEVIATION 1.43 • n=4 Participants	19.95 years STANDARD_DEVIATION 1.41 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	23 participants n=93 Participants	21 participants n=4 Participants	44 participants n=27 Participants
Drinking Days (%)	34.32 Percentage STANDARD_DEVIATION 11.78 • n=93 Participants	37.07 Percentage STANDARD_DEVIATION 19.22 • n=4 Participants	35.63 Percentage STANDARD_DEVIATION 9.98 • n=27 Participants
Alcohol drinks consumed per drinking day (Mean)	4.35 Count of Standard Alcoholic Drinks STANDARD_DEVIATION 1.49 • n=93 Participants	4.15 Count of Standard Alcoholic Drinks STANDARD_DEVIATION 1.55 • n=4 Participants	4.25 Count of Standard Alcoholic Drinks STANDARD_DEVIATION 1.50 • n=27 Participants

PRIMARY outcome

Timeframe: 9-week active treatment phase

The number and percentage of youth who complete the active medication phase will determine feasibility.

Outcome measures

Outcome measures
Measure	Lamotrigine n=23 Participants Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo n=21 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Completion Rates	22 Participants	19 Participants

PRIMARY outcome

Timeframe: 9-week active treatment phase

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%.

Outcome measures

Outcome measures
Measure	Lamotrigine n=23 Participants Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo n=21 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Acceptability of the Study Medication	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 9-week active treatment phase

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).

Outcome measures

Outcome measures
Measure	Lamotrigine n=22 Participants Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo n=18 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Alcohol Craving	3.14 units on a scale Standard Deviation 3.41	3.81 units on a scale Standard Deviation 4.57

Adverse Events

Lamotrigine

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Robert Miranda Jr.

Brown University

Phone: 401-863-6658

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lamotrigine n=23 participants at risk Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks Lamotrigine: 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).	Placebo n=21 participants at risk Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Psychiatric disorders Agitation	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	14.3% 3/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Psychiatric disorders Anxiety	21.7% 5/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Metabolism and nutrition disorders Loss of Appetite	13.0% 3/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	0.00% 0/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Body Aches	13.0% 3/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	14.3% 3/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Chills	8.7% 2/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	0.00% 0/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Eye disorders Conjunctivitis	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	9.5% 2/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Skin and subcutaneous tissue disorders Contact Dermatitis	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	9.5% 2/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Respiratory, thoracic and mediastinal disorders Cough	17.4% 4/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	0.00% 0/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Gastrointestinal disorders Diarrhea	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Fatigue	8.7% 2/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	23.8% 5/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Fever	0.00% 0/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	14.3% 3/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Flu-like symptoms	21.7% 5/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	14.3% 3/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Headache	52.2% 12/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	23.8% 5/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Sweating	0.00% 0/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	9.5% 2/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Cardiac disorders Hypertension	39.1% 9/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	42.9% 9/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Hypoglycemia	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	19.0% 4/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Psychiatric disorders Impaired Memory	8.7% 2/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Insomnia	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Reproductive system and breast disorders Irregular Menstruation	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	8.7% 2/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	23.8% 5/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Gastrointestinal disorders Nausea	26.1% 6/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	4.8% 1/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
Skin and subcutaneous tissue disorders Rash	4.3% 1/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	14.3% 3/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Soar Throat	21.7% 5/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	9.5% 2/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.
General disorders Vomiting	8.7% 2/23 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.	0.00% 0/21 • 9-week treatment period Participants are specifically queried each week regarding any adverse events since their last study appointment.