Alcohol Use DisorderPhase 2ACGTNCT03897348
Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)
A Phase 2 study testing Lacosamide 100 mg and Lacosamide 200 mg in people with Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Lacosamide 100 mg and Lacosamide 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 12 Jun 2019
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- Meet DSM-V criteria for current alcohol use disorder (AUD);
- Average weekly alcohol use of 25-70 standard drinks for men over the past 30 days;
- No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
Who cannot join
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco or cannabis;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines or barbiturates;
- Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
- Taking medications that may interact with lacosamide, e.g. medications that prolong the ECG PR interval, or medications with strong CYP3A4 and CYP2C9;
- Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
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- Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol;
- Medical conditions that in the judgment of the study physician contraindicate LAC (non contraindications listed in the FDA-approved Prescribing Information for LAC);
- Any other medical conditions that in the opinion of the study physician would make study participation hazardous;
- History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score greater than or equal to 8;
- Participants who report disliking spirits will be excluded because 80 proof liquor will be provided during the alcohol self-administration periods;
- Participants who have taken any investigational drug within 4 weeks preceding study entry;
- Participants with first-degree atrioventricular block (AV block), PR interval lengthened beyond 0.20 seconds or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Health Care System
San Francisco, California, 94121
About this study
Official title: A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder
The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.
Read the detailed description
Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo.
The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study.
- Conditions
- Alcohol Use Disorder
- Being tested
- Placebo, Lacosamide 100 mg, Lacosamide 200 mg
- Keywords
- alcohol craving, human laboratory, lacosamide, non-treatment seeking
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo capsule identical in appearance to Lacosamide 100 mg and 200 mg capsules.
Oral medication
Lacosamide 100 mgDrug
Also called Lacosamide 100 mg capsule identical in appearance to Placebo and Lacosamide 200 mg capsule
Oral medication
Lacosamide 200 mgDrug
Also called Lacosamide 200 mg capsule identical in appearance to Placebo and Lacosamide 100 mg capsules.
Oral medication
| Study group | Role | What they receive |
|---|---|---|
| Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg | Experimental | Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. Receives: Drug: Placebo; Drug: Lacosamide 100 mg; Drug: Lacosamide 200 mg |
| Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo | Experimental | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. Receives: Drug: Placebo; Drug: Lacosamide 100 mg; Drug: Lacosamide 200 mg |
| Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg | Experimental | Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. Receives: Drug: Placebo; Drug: Lacosamide 100 mg; Drug: Lacosamide 200 mg |
| Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo | Experimental | Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. Receives: Drug: Placebo; Drug: Lacosamide 100 mg; Drug: Lacosamide 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures
Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.
Measured: 7 months
Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)
Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.
Measured: 6.5 weeks
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo).
Measured: 3 days (1 day each for ADP Session 1, 2, and 3)
Secondary outcomes (3)
Alcohol Craving
Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before study medication and at various times after study medication. The AUQ score reported here is the highest AUQ score following administration of study medication.
Measured: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Alcohol Consumption (Number of Standard Drinks Consumed)
Alcohol consumption is measured during each of the Alcohol Drinking Paradigm (ADP) sessions, 1, 2 and 3. In each session participants received one of the 3 drug interventions, Placebo, Lacosamide 100 mg, or Lacosamide 200 mg. Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.
Measured: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Subjective Effects of Alcohol Consumption
Subjective effects of alcohol consumption are measured during the Alcohol Drinking Paradigm (ADP) sessions 1, 2 and 3 using the Biphasic Alcohol Effects Scale (BAES), which has 2 subscales; the Stimulation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest stimulation; the Sedation Subscale range is 0 - 70, where 0 is the least and 70 is the greatest sedation. The BAES was administered both before and at various timepoints after study medication administration in each of the ADP sessions. The BAES scores reported here are the peak Stimulation scores after medication administration and peak Sedation scores after medication administration for each of ADP sessions 1, 2 and 3.
Measured: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start17 Sep 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
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.
- More trials run by University of California, San FranciscoThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Responsible party
- Sponsor
- Investigators
- Steven L. Batki, MD, Principal investigator, UCSF/SFVAHCS/NCIRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897348
- Sponsor's protocol ID
- 17-22180
- Acronym
- ACGT
- Status last verified
- Jun 2022
- First submitted
- 2 Jan 2019
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03897348
- Acronym / sponsor ID
- ACGT / 17-22180
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol craving, human laboratory, lacosamide, non-treatment seeking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco VA Health Care System
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.
Detailed description
Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo.
The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg | Experimental | Drug: Placebo, Drug: Lacosamide 100 mg, Drug: Lacosamide 200 mgParticipants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. |
| Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo | Experimental | Drug: Placebo, Drug: Lacosamide 100 mg, Drug: Lacosamide 200 mgParticipants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. |
| Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg | Experimental | Drug: Placebo, Drug: Lacosamide 100 mg, Drug: Lacosamide 200 mgParticipants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg. |
| Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo | Experimental | Drug: Placebo, Drug: Lacosamide 100 mg, Drug: Lacosamide 200 mgParticipants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- Meet DSM-V criteria for current alcohol use disorder (AUD);
- Average weekly alcohol use of 25-70 standard drinks for men over the past 30 days;
- No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
Key exclusion criteria (13 listed)
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco or cannabis;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines or barbiturates;
- Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
- Taking medications that may interact with lacosamide, e.g. medications that prolong the ECG PR interval, or medications with strong CYP3A4 and CYP2C9;
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 |
|---|---|---|
| PlaceboAlso: Placebo capsule identical in appearance to Lacosamide 100 mg and 200 mg capsules.Oral medication | Drug | Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg, Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo, Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg, Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo |
| Lacosamide 100 mgAlso: Lacosamide 100 mg capsule identical in appearance to Placebo and Lacosamide 200 mg capsuleOral medication | Drug | Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg, Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo, Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg, Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo |
| Lacosamide 200 mgAlso: Lacosamide 200 mg capsule identical in appearance to Placebo and Lacosamide 100 mg capsules.Oral medication | Drug | Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg, Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo, Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg, Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo |
Primary outcome
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures
Time frame: 7 months
Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.
Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)
Time frame: 6.5 weeks
Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
Time frame: 3 days (1 day each for ADP Session 1, 2, and 3)
Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo).
3 secondary outcomes
Alcohol Craving
Time frame: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Alcohol Consumption (Number of Standard Drinks Consumed)
Time frame: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Subjective Effects of Alcohol Consumption
Time frame: 3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven L. Batki, MD principal investigator
UCSF/SFVAHCS/NCIRE
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 Lacosamide 100 mg and Lacosamide 200 mg in people with Alcohol Use Disorder, run by University of California, San Francisco 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 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: finished, as of the sponsor's last update on 28 Jun 2022. 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. 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 27 Oct 2021). 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?
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures (time frame: 7 months). The study lists 3 primary outcomes in all. 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 28 Jun 2022.