Alcohol Use DisorderPhase 1/2NCT03896516
Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder
A Phase 1/2 study testing GLWL-01 in people with Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: People with alcohol use disorder (AUD) have trouble controlling their drinking. Medications can help some people with AUD but are not effective for many others. Researchers want to test new drugs to better treat the disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- GLWL-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 4 Dec 2023
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol Use Disorder (Minimum 2 symptoms on a validated diagnostic tool e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID)
- Male or female individuals 18-70 years old (inclusive)
- Able to speak, read, write and understand English
- Most recent urine drug test for benzodiazepines, barbiturates, cocaine metabolites, morphine, oxycodone, methadone, amphetamine, \& buprenorphine is negative.
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is less than or equal to 8
- Males only:
Show all 19Show fewer
- -Males agrees agree to sexual abstinence or to use a reliable method of birth control during the study and three months following the last dose of the study drug. Acceptable methods of birth control may include: 1) condom with spermicide; 2) diaphragm with spermicide; or 3) female condom with spermicide.
- Females only:
- -Women of child-bearing potential may participate in the study:
- if they test negative for pregnancy (based on a urine pregnancy test) prior to initiation of treatment
- they must also agree to use either one highly effective method of contraception or a combination of two effective methods of contraception during the study.
- Highly effective method may include hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or/ intrauterine system; vasectomy and tubal ligation.
- Effective methods may include barrier methods of contraception (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge)
- Women may choose to use a double-barrier method of contraception. Barrier methods without concomitant use of a spermicide are not reliable or an acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined.
- OR
- -Women not of child-bearing potential may participate in the study and include those who have
- spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced amenorrhea e.g., oral contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy; or
- spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 mIU/mL; or
- women with a history of hysterectomy or bilateral oophorectomy must be at least 40 years of age and FSH >40 mIU/mL.
Who cannot join
- Lifetime clinical diagnosis of schizophrenia or bipolar disorder
- BMI < 18.5 kg/m(2) and weight less than 60 Kg (both must be met)
- BMI >= 40 kg/m(2)
- History of epilepsy and/or seizures
- NOTE: individuals who have a history of alcohol withdrawal seizures may be in the study as long as they have been abstinent from alcohol for at least 2 weeks prior to consent and during that period of abstinence, there were no seizure episodes (otherwise, participant remains not eligible).
- Creatinine greater than or equal to 2 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper normal limit, hemoglobin <10.5 g/dl
Show all 29Show fewer
- Diagnosis of liver cirrhosis
- Clinically significant history or current eating, pituitary or adrenal gland disorders or disorder of gastric motility as judged by a study clinician as determined from medical history and/or current clinical screening information
- Current thyroid disorders that are not stable on dose of FDA-approved medications for that disease, as judged by a study clinician as determined from medical history and/or current clinical screening information. A pre-existing stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the past 3 months.
- Clinically significant abnormal 12-Lead ECG
- QTcF > 450 msec for men and > 470 msec for women
- Family history of Long QT Syndrome.
- Patients on weight loss medications within 30 days of dosing
- Patients with a history of bariatric surgery
- Diagnosis of diabetes and currently on medication
- Unable to refrain from or anticipates the use of:
- Any drugs known to be significant inhibitors of cytochrome P450 (CYP)3A enzymes and/or P-glycoprotein (P-gp) including regular consumption of grapefruit or grapefruit juice for 14 days prior to the first dose of study medication.
- [medications like acetaminophen (up to 2 g per 24-hour period) and ibuprofen may be permitted during the study]
- Any drugs known to be significant inducers of CYP3A enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dose of study medication.
- Any medications that prolong the QTcF, unless the patient has been stable on the medication for at least 3 months and has a QTcF equal to or < 450 msec
- Benzodiazepines. If a participant received a benzodiazepine as part of their treatment during the alcohol detoxification, then s/he can still be enrolled. However, 5 half-lives (for that benzodiazepine) will be required to elapse before the anticipated date of first study drug administration
- Currently taking simvastatin >10 mg per day, atorvastatin >20 mg per day, or lovastatin >20 mg per day.
- The doses of these statins in combination products should not exceed these defined dose levels.
- Patients with a history of statin-induced myopathy/rhabdomyolysis.
- Vision is unable to be corrected to (Snellen) 20/100
- Clinically-significant history of motion or car sickness, or history of vestibular disorders
- FIB-4 Score > 1.30
- Any other reason or clinical condition for which the PI or the MAI or other study clinician will consider unsafe for a possible participant to participate in this study
- These criteria are based on the target population for this study. Other criteria are consistent with an ongoing study that GLWL Research Inc. is conducting with GLWL-01 in patients with Prader-Willi Syndrome (ClinicalTrials.gov NCT03274856).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
People with alcohol use disorder (AUD) have trouble controlling their drinking. Medications can help some people with AUD but are not effective for many others. Researchers want to test new drugs to better treat the disease.
Read more
Objective:
To see if the investigational drug GLWL-01 is safe to use in people with alcohol problems. Also, to find out if the drug reduces the urge to drink alcohol.
Eligibility:
People ages 18-70 with Alcohol Use Disorder (AUD)
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will be admitted to the inpatient facility, Clinical Research Unit (CRU) on the Johns Hopkins Bayview Medical Center for up to 21 days. They may leave the CRU on specified days pending approval. All their meals will be provided. They cannot drink alcohol.
Participants will take either the study drug or a placebo by mouth twice daily. They will not know which they are receiving.
Participants will complete many questionnaires.
Participants may have urine tests.
Participants will complete tasks on a computer.
Participants will have blood samples obtained on some study days.
Participants will taste and indicate their preference for sweet liquids.
Participants' blood pressure, pulse, respiratory rate, body temperature and weight, heart rate and rhythm will be measured.
Participants will have breath testing to obtain information about smoking.
Participants will be exposed to alcohol cues, water, and food cues in a bar-like room. Cues are things that might make them feel the urge to eat or drink alcohol.
Participants will take part in a virtual buffet experiment - They will wear a virtual reality headset, walk around a virtual room, and select virtual food and drink.
Read the detailed description
Background and Objective: Acyl-ghrelin is a 28-amino acid peptide that stimulates appetite and food intake. It is an endogenous ligand for the growth hormone secretagogue receptor (GHS-R1a). Preclinical studies suggest that acyl-ghrelin increases alcohol intake and decreases in acyl-ghrelin and GHS-R1a function suppresses alcohol consumption. Furthermore, previous human studies indicate a positive correlation between endogenous ghrelin levels and alcohol craving and drinking. In clinical studies conducted by our group with individuals with AUD, intravenous (IV) acyl-ghrelin administration, versus placebo 1) increased alcohol craving during alcohol cue-exposure and 2) increased IV alcohol self-administration as well as decreased latency to first infusion of alcohol and 3) increased brain activation in the amygdala in anticipation of alcohol reward.
Together, this preclinical and human data suggest that manipulating the ghrelin signal may be a novel and potentially effective pharmacological approach to treat individuals with alcohol use disorder.
After the discoveries of GHS-R1a and acyl-ghrelin, a next step was identifying ghrelin O-acyltransferase (GOAT) the enzyme that catalyzes the conversion of des-acyl-ghrelin (DAG) to acyl-ghrelin via octanoylation. GOAT is thus the master switch for the ghrelin system , as acyl-ghrelin, not DAG, is biologically active at the GHSR-1a. GOAT s structure is highly conserved, is produced by endocrine cells in the stomach and is co-expressed with ghrelin. Therefore, GOAT is a promising target for manipulating the ghrelin system by altering the peripheral acyl-to-total ghrelin ratio (where total ghrelin = acyl-ghrelin + DAG). Recently, the ghrelin system has been investigated as a potential treatment target for AUDs.
As such, an oral bioavailable GOAT inhibitor offers encouraging potential as a treatment for alcohol use disorder. GLWL-01 is an existing GOAT inhibitor for which GLWL Research Inc. has recently and successfully completed a first-in-human safety clinical trial. The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess a potential early signal of efficacy of GLWL-01 in relation to alcohol-related outcomes.
Study population: Males and females (N = 43) with alcohol use disorder.
Study Design: A within-subject, counterbalanced, double-blind, placebo-controlled study. Participants will take GLWL-01 450 mg b.i.d. or matched placebo for a minimum of 4 days (Stage I). After a minimum 2 day wash-out window, Stage II will take place during which the counterbalanced study drug will be administered for a minimum of 4 days.
Primary outcome measure: The co-primary aims will be to determine whether: 1) the number of adverse events (AEs) experienced differ in the GLWL-01 condition, compared to placebo; and 2) GLWL-01, compared to placebo, reduces alcohol cue-elicited craving using a validated alcohol cue-reactivity procedure.
Secondary outcome measures: The main secondary aim will be the effects of GLWL-01 on food choices using a virtual buffet experimental procedure. We will also monitor a wide range of behavioral measures including e.g., pain, anxiety, depression, alcohol craving and withdrawal, and smoking.
- Conditions
- Alcohol Use Disorder
- Being tested
- Placebo, GLWL-01
- Keywords
- Alcohol Problems, Alcohol Craving, Food-Seeking Behaviors, Ghrelin, Ghrelin O-acyltransferase
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Participants receive Placebo orally twice daily.
GLWL-01Drug
GLWL-01 is a ghrelin O-acyltransferase (GOAT) inhibitor. Participants receive GLWL-01 orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| GLWL-01, then Placebo | Experimental | Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then placebo orally twice daily for a minimum of four days (stage II). Receives: Other: Placebo; Drug: GLWL-01 |
| Placebo, then GLWL-01 | Placebo comparator | Participants receive placebo orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then GLWL-01 450 mg orally twice daily for a minimum of four days (stage II). Receives: Other: Placebo; Drug: GLWL-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Number of participants with adverse events related to intervention. Adverse events were collected from participants self reporting.
Measured: Up to one month
Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). Higher score indicated higher alcohol craving.
AUQ was collected on each initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day), for a total of 5-6 days per intervention. The least squares average for each intervention was calculated using a linear mixed effects model including a random intercept for each participant.
Measured: AUQ scores were collected 5-6 days per intervention [initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day)]
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 start22 Jun 2021
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896516
- Sponsor's protocol ID
- 999919075
- Other IDs
- 19-DA-N075
- Status last verified
- 12 Mar 2024
- First submitted
- 27 Mar 2019
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: .Data sharing with other protocols. Data obtained under this protocol and the National Institute on Drug Abuse (NIDA) screening protocol may be shared and combined for analysis. This will also allow us to avoid repeating assessments that are scheduled in both protocols during the same period of time, therefore avoiding duplication and minimizing participant fatigue. Participants may also consent for other NIH protocols and data collected under those protocols may be combined with data from this protocol for exploratory purposes. This protocol does not meet criteria for genomic data sharing. NIH Human Data Sharing (HDS) policy is not applied in this protocol because it is limited by the agreement (CRADA) with GLWL Research Inc.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating Ghrelin Signaling Via GOAT Inhibition in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03896516
- Acronym / sponsor ID
- 999919075
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol Problems, Alcohol Craving, Food-Seeking Behaviors, Ghrelin, Ghrelin O-acyltransferase
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
People with alcohol use disorder (AUD) have trouble controlling their drinking. Medications can help some people with AUD but are not effective for many others. Researchers want to test new drugs to better treat the disease.
Objective:
To see if the investigational drug GLWL-01 is safe to use in people with alcohol problems. Also, to find out if the drug reduces the urge to drink alcohol.
Eligibility:
People ages 18-70 with Alcohol Use Disorder (AUD)
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will be admitted to the inpatient facility, Clinical Research Unit (CRU) on the Johns Hopkins Bayview Medical Center for up to 21 days. They may leave the CRU on specified days pending approval. All their meals will be provided. They cannot drink alcohol.
Participants will take either the study drug or a placebo by mouth twice daily. They will not know which they are receiving.
Participants will complete many questionnaires.
Participants may have urine tests.
Participants will complete tasks on a computer.
Participants will have blood samples obtained on some study days.
Participants will taste and indicate their preference for sweet liquids.
Participants' blood pressure, pulse, respiratory rate, body temperature and weight, heart rate and rhythm will be measured.
Participants will have breath testing to obtain information about smoking.
Participants will be exposed to alcohol cues, water, and food cues in a bar-like room. Cues are things that might make them feel the urge to eat or drink alcohol.
Participants will take part in a virtual buffet experiment - They will wear a virtual reality headset, walk around a virtual room, and select virtual food and drink.
Detailed description
Background and Objective: Acyl-ghrelin is a 28-amino acid peptide that stimulates appetite and food intake. It is an endogenous ligand for the growth hormone secretagogue receptor (GHS-R1a). Preclinical studies suggest that acyl-ghrelin increases alcohol intake and decreases in acyl-ghrelin and GHS-R1a function suppresses alcohol consumption. Furthermore, previous human studies indicate a positive correlation between endogenous ghrelin levels and alcohol craving and drinking. In clinical studies conducted by our group with individuals with AUD, intravenous (IV) acyl-ghrelin administration, versus placebo 1) increased alcohol craving during alcohol cue-exposure and 2) increased IV alcohol self-administration as well as decreased latency to first infusion of alcohol and 3) increased brain activation in the amygdala in anticipation of alcohol reward.
Together, this preclinical and human data suggest that manipulating the ghrelin signal may be a novel and potentially effective pharmacological approach to treat individuals with alcohol use disorder.
After the discoveries of GHS-R1a and acyl-ghrelin, a next step was identifying ghrelin O-acyltransferase (GOAT) the enzyme that catalyzes the conversion of des-acyl-ghrelin (DAG) to acyl-ghrelin via octanoylation. GOAT is thus the master switch for the ghrelin system , as acyl-ghrelin, not DAG, is biologically active at the GHSR-1a. GOAT s structure is highly conserved, is produced by endocrine cells in the stomach and is co-expressed with ghrelin. Therefore, GOAT is a promising target for manipulating the ghrelin system by altering the peripheral acyl-to-total ghrelin ratio (where total ghrelin = acyl-ghrelin + DAG). Recently, the ghrelin system has been investigated as a potential treatment target for AUDs.
As such, an oral bioavailable GOAT inhibitor offers encouraging potential as a treatment for alcohol use disorder. GLWL-01 is an existing GOAT inhibitor for which GLWL Research Inc. has recently and successfully completed a first-in-human safety clinical trial. The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess a potential early signal of efficacy of GLWL-01 in relation to alcohol-related outcomes.
Study population: Males and females (N = 43) with alcohol use disorder.
Study Design: A within-subject, counterbalanced, double-blind, placebo-controlled study. Participants will take GLWL-01 450 mg b.i.d. or matched placebo for a minimum of 4 days (Stage I). After a minimum 2 day wash-out window, Stage II will take place during which the counterbalanced study drug will be administered for a minimum of 4 days.
Primary outcome measure: The co-primary aims will be to determine whether: 1) the number of adverse events (AEs) experienced differ in the GLWL-01 condition, compared to placebo; and 2) GLWL-01, compared to placebo, reduces alcohol cue-elicited craving using a validated alcohol cue-reactivity procedure.
Secondary outcome measures: The main secondary aim will be the effects of GLWL-01 on food choices using a virtual buffet experimental procedure. We will also monitor a wide range of behavioral measures including e.g., pain, anxiety, depression, alcohol craving and withdrawal, and smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLWL-01, then Placebo | Experimental | Other: Placebo, Drug: GLWL-01Participants receive GLWL-01 450 mg orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then placebo orally twice daily for a minimum of four days (stage II). |
| Placebo, then GLWL-01 | Placebo comparator | Other: Placebo, Drug: GLWL-01Participants receive placebo orally twice daily for a minimum of four days (Stage I) followed by a minimum of two day wash-out period then GLWL-01 450 mg orally twice daily for a minimum of four days (stage II). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Alcohol Use Disorder (Minimum 2 symptoms on a validated diagnostic tool e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID)
- Male or female individuals 18-70 years old (inclusive)
- Able to speak, read, write and understand English
- Most recent urine drug test for benzodiazepines, barbiturates, cocaine metabolites, morphine, oxycodone, methadone, amphetamine, \& buprenorphine is negative.
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is less than or equal to 8
Key exclusion criteria (29 listed)
- Lifetime clinical diagnosis of schizophrenia or bipolar disorder
- BMI < 18.5 kg/m(2) and weight less than 60 Kg (both must be met)
- BMI >= 40 kg/m(2)
- History of epilepsy and/or seizures
- NOTE: individuals who have a history of alcohol withdrawal seizures may be in the study as long as they have been abstinent from alcohol for at least 2 weeks prior to consent and during that period of abstinence, there were no seizure episodes (otherwise, participant remains not eligible).
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 |
|---|---|---|
| PlaceboParticipants receive Placebo orally twice daily. | Other | GLWL-01, then Placebo, Placebo, then GLWL-01 |
| GLWL-01GLWL-01 is a ghrelin O-acyltransferase (GOAT) inhibitor. Participants receive GLWL-01 orally twice daily. | Drug | GLWL-01, then Placebo, Placebo, then GLWL-01 |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to one month
Number of participants with adverse events related to intervention. Adverse events were collected from participants self reporting.
Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
Time frame: AUQ scores were collected 5-6 days per intervention [initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day)]
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). Higher score indicated higher alcohol craving. AUQ was collected on each initial dosing days (2-3 days), the virtual reality buffet day (1 day), the cue-reactivity day (1 day), and the final study day (1 day), for a total of 5-6 days per intervention. The least squares average for each intervention was calculated using a linear mixed effects model including a random intercept for each participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. .Data sharing with other protocols. Data obtained under this protocol and the National Institute on Drug Abuse (NIDA) screening protocol may be shared and combined for analysis. This will also allow us to avoid repeating assessments that are scheduled in both protocols during the same period of time, therefore avoiding duplication and minimizing participant fatigue. Participants may also consent for other NIH protocols and data collected under those protocols may be combined with data from this protocol for exploratory purposes. This protocol does not meet criteria for genomic data sharing. NIH Human Data Sharing (HDS) policy is not applied in this protocol because it is limited by the agreement (CRADA) with GLWL Research Inc.
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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.
Lorenzo Leggio, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLWL-01 in people with Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) 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 19 inclusion and 29 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 15 Jan 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 15 Jan 2025). 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?
Number of Participants With Adverse Events (AEs) (time frame: Up to one month). 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 15 Jan 2025.