Alcohol Use DisorderPhase 2NCT04157114
MAP4343 Treatment for Alcohol Use Disorder
A Phase 2 study testing MAP4343 and Standardized behavioral counseling in people with Alcohol Use Disorder, run by The Scripps Research Institute at 1 site in United States.
Trial summary
This is a Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- MAP4343 and Standardized behavioral counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers, 18-65 years of age
- Meets Diagnostic and Statistical Manual (DSM)-5 criteria for current Alcohol Use Disorder (AUD) of moderate or greater severity, defined by DSM-5 as ≥ 4 symptoms
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (males: ≥ 5 drinks, females: ≥ 4 drinks) per week
- Seeking research-based outpatient treatment for AUD and willing to comply with the protocol, take daily oral medication for 6 weeks and complete 10 study visits
- Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
- Negative Blood Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of ≤ 9 at randomization
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- In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, electrocardiogram (ECG), urine test, and routine lab tests
- Females with childbearing potential must have a negative pregnancy test on both the screening and randomization visits and agree to use non-hormonal effective birth control for the study duration and 1 month post treatment.
- Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
Who cannot join
- Significant medical disorders or clinically significant findings on ECG, urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician
- Liver function tests more than 3 times the upper limit of normal
- Meets DSM-5 criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders or mild cannabis use disorder
- Urine drug test positive at screening for abused drugs other than cannabis. Subjects using cannabis will be excluded if they meet criteria for cannabis use disorder ≥ moderate level of severity
- Treatment within the month prior to screening with an investigational drug or vaccine, or drugs that may influence study outcomes, e.g., disulfiram, naltrexone, acamprosate
- Chronic use or need for psychotropic drugs. Note: some drugs with psychotropic properties (e.g., anti-hypertensive drugs) or antidepressant medication taken at a stable dose for ≥ 3 months and no longer meeting criteria for depressive or anxiety disorders are allowed if their use is judged by both the investigator and study physician not to pose a safety risk or impact the results of the study
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- No fixed domicile and/or no availability by home or mobile telephone
- Treatment mandated by a legal authority
- Failure to comply with study procedures
- Subjects who require medical detoxification (Note: Subjects may proceed with study evaluation after completion of detoxification)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, 92037
About this study
Official title: A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder
This is a Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment.
- Conditions
- Alcohol Use Disorder
- Being tested
- MAP4343, Placebo, Standardized behavioral counseling
- Keywords
- Alcohol-Related Disorders, Substance-Related Disorders, MAP4343, Alcohol Treatment, Alcohol
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP4343Drug
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
PlaceboDrug
Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Standardized behavioral counselingBehavioural
Also called Manually-guided therapy
Subjects receive manually-guided counseling 1 time per week for a 6 week duration
| Study group | Role | What they receive |
|---|---|---|
| MAP4343 | Active comparator | Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling Receives: Drug: MAP4343; Behavioral: Standardized behavioral counseling |
| Placebo | Placebo comparator | Subjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling Receives: Drug: Placebo; Behavioral: Standardized behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-Back (TLFB) Interview
The Timeline Follow-Back Interview provides quantity and frequency estimates of alcohol consumption for the 90-day period prior to and throughout the study.
Measured: 90-day period prior to and throughout the study
Visual Analogue Scale of Craving (VAS; adapted from ACQ)
The Visual Analogue Scale of Craving has 4 questions to assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity with a 0-20 point visual analogue scale for each item, with 0 indicating no craving and 20 indicating severe craving.
Measured: At subject's Week 2 human laboratory session
Secondary outcomes (4)
Alcohol Craving Questionnaire-Short Form (ACQ-SF)
The Alcohol Craving Questionnaire-Short Form has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving.
Measured: Subjects will followed for up to 10 weeks
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0-3, summed for a weekly total score between 0 and 63, higher scores indicate more depression.
Measured: Subjects will be followed for up to 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index, modified for weekly administration, consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher scores indicating greater sleep impairment.
Measured: Subjects will be followed for up to 10 weeks
State-Trait Anxiety Inventory (STAI)
The State-Trait Inventory has 20 questions for assessing state anxiety and 20 for trait anxiety answered with scores between 1-4, summed for a weekly total score between 20 and 80, higher scores indicate more anxiety.
Measured: Subjects will be followed for up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The FDA requested Mapreg conduct an alcohol interaction study which was not feasible due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Mapreg
- Responsible party
- Principal investigator, Barbara J. Mason, The Scripps Research Institute
- Investigators
- Barbara J. Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157114
- Sponsor's protocol ID
- MAP2019
- Other IDs
- P60AA006420
- Status last verified
- Feb 2022
- First submitted
- 6 Nov 2019
- Last updated
- 11 Mar 2022
- Results posted
- No
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04157114
- Acronym / sponsor ID
- MAP2019
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol-Related Disorders, Substance-Related Disorders, MAP4343, Alcohol Treatment, Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The FDA requested Mapreg conduct an alcohol interaction study which was not feasible due to the COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Mapreg
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
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 Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment.
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
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| MAP4343 | Active comparator | Drug: MAP4343, Behavioral: Standardized behavioral counselingSubjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Standardized behavioral counselingSubjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female volunteers, 18-65 years of age
- Meets Diagnostic and Statistical Manual (DSM)-5 criteria for current Alcohol Use Disorder (AUD) of moderate or greater severity, defined by DSM-5 as ≥ 4 symptoms
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (males: ≥ 5 drinks, females: ≥ 4 drinks) per week
- Seeking research-based outpatient treatment for AUD and willing to comply with the protocol, take daily oral medication for 6 weeks and complete 10 study visits
- Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
Key exclusion criteria (10 listed)
- Significant medical disorders or clinically significant findings on ECG, urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician
- Liver function tests more than 3 times the upper limit of normal
- Meets DSM-5 criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders or mild cannabis use disorder
- Urine drug test positive at screening for abused drugs other than cannabis. Subjects using cannabis will be excluded if they meet criteria for cannabis use disorder ≥ moderate level of severity
- Treatment within the month prior to screening with an investigational drug or vaccine, or drugs that may influence study outcomes, e.g., disulfiram, naltrexone, acamprosate
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 |
|---|---|---|
| MAP4343Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling | Drug | MAP4343 |
| PlaceboSubjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling | Drug | Placebo |
| Standardized behavioral counselingAlso: Manually-guided therapySubjects receive manually-guided counseling 1 time per week for a 6 week duration | Behavioural | MAP4343, Placebo |
Primary outcome
Timeline Follow-Back (TLFB) Interview
Time frame: 90-day period prior to and throughout the study
The Timeline Follow-Back Interview provides quantity and frequency estimates of alcohol consumption for the 90-day period prior to and throughout the study.
Visual Analogue Scale of Craving (VAS; adapted from ACQ)
Time frame: At subject's Week 2 human laboratory session
The Visual Analogue Scale of Craving has 4 questions to assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity with a 0-20 point visual analogue scale for each item, with 0 indicating no craving and 20 indicating severe craving.
4 secondary outcomes
Alcohol Craving Questionnaire-Short Form (ACQ-SF)
Time frame: Subjects will followed for up to 10 weeks
Beck Depression Inventory (BDI-II)
Time frame: Subjects will be followed for up to 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Subjects will be followed for up to 10 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Subjects will be followed for up to 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- 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.
Barbara J. Mason, Ph.D. principal investigator
The Scripps Research Institute
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 MAP4343 and Standardized behavioral counseling in people with Alcohol Use Disorder, run by The Scripps Research Institute 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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 11 Mar 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Timeline Follow-Back (TLFB) Interview (time frame: 90-day period prior to and throughout the study). The study lists 2 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 11 Mar 2022.