Alcohol Use DisordersPhase 1NCT02025998
Development of Ibudilast for Alcohol Use Disorder
A Phase 1 study testing Ibudilast in people with Alcohol Use Disorders, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- Ibudilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 21 and 65
- meet DSM-IV diagnostic criteria for alcohol abuse or dependence
- report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment
Who cannot join
- current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
- current (last 12 months) DSM-IV diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
- lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R);
- pregnancy, nursing, or refusal to use reliable method of birth control (if female);
Show all 11Show fewer
- medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
- AST, ALT, or GGT ≥ 3 times upper normal limit;
- attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year;
- currently on prescription medication that contraindicates use of IBUD;
- any other circumstances that, in the opinion of the investigators, compromises participant safety
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Addictions Laboratory
Los Angeles, California, 90095
About this study
Official title: Development of Ibudilast as a Novel Treatment for Alcohol Dependence
The objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders.
Read the detailed description
Alcohol dependence (AD) is a chronic and relapsing condition affecting 10 million Americans. To date, only four pharmacotherapies are approved by the FDA for the treatment of alcoholism and their efficacy is modest. Therefore, medication development for AD represents a high priority area. Ibudilast (IBUD) is a glial cell modulator that inhibits phosphodiesterases (PDE) -4 and -10 and macrophage migration inhibitory factor (MIF). Preclinical data suggest that neuroimmune modulation is critical to the rewarding properties of drugs of abuse, including alcohol. Further, IBUD has been shown to enhance GDNF release in vivo and GDNF modulation has been implicated in alcohol reinstatement in animals, while PDE inhibition has been shown to reduce alcohol intake in mice. Together, these findings suggest that neuroimmune modulation constitutes a novel target for the treatment of alcoholism. The objective of this study is to advance medication development for alcoholism by conducting an initial Phase II study of IBUD for AD. Specifically, the proposed study consists of a randomized, double-blind, placebo-controlled within-subject crossover design to determine the safety, tolerability, and initial human laboratory efficacy of IBUD in a sample of 24 non-treatment seeking individuals with either alcohol abuse or dependence treated with IBUD (50mg BID) and placebo. Participants will complete two separate 7-day inpatient stays at the UCLA CTRC during which they will take the study medication, complete an IV alcohol challenge, and take part in a stress-exposure and cue-exposure paradigms. Specific aims are to test whether IBUD (a) is safe in the context of alcohol administration, (b) attenuates alcohol-induced reinforcement, and (c) dampens stress-induced and cue-induced alcohol craving. In sum, this study will efficiently evaluate safety and initial efficacy of IBUD thereby screening novel medications for AD and elucidating potential mechanisms by which IBUD may be clinically efficacious. Results from this study will inform whether a randomized controlled trial of IBUD for alcoholism is warranted.
- Conditions
- Alcohol Use Disorders
- Being tested
- Ibudilast, Matched placebo
- Keywords
- ibudilast, alcoholism
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbudilastDrug
Also called MN-166, AV411
Ibudilast is a glial cell modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor.
Matched placeboOther
Also called Suggar pill
A matched placebo (suggar pill) will be administered as a control condition.
| Study group | Role | What they receive |
|---|---|---|
| Ibudilast | Experimental | Ibudilast will be administered for 7 days at the target dose of 50 mg/bid Receives: Drug: Ibudilast |
| Sugar pill | Placebo comparator | Placebo pills will be administered for 7 days and taken twice daily Receives: Other: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective response to alcohol
Biphasic Alcohol Effects Scale (BAES) Alcohol Urge Questionnaire (AUQ)
Measured: During the alcohol administration and observation period which is expected to last a total of 4 hours
Secondary outcomes (2)
Stress-Induced Craving
Alcohol Urge Questionnaire (AUQ) \& Differential Emotion Scale (DES)
Measured: During the stress exposure and observation period which is expected to last a total of 2 hours
Cue-Induced Alcohol Craving
Alcohol Urge Questionnaire (AUQ)
Measured: During the cue-exposure and observation period which is expected to last a total of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Lara Ray, University of California, Los Angeles
- Investigators
- Lara Ray, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025998
- Sponsor's protocol ID
- IBUD
- Other IDs
- R21AA022214
- Status last verified
- Feb 2016
- First submitted
- 19 Dec 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Meredith LR, Green R, Grodin EN, Chorpita M, Miotto K, Ray LA. Ibudilast moderates the effect of mood on alcohol craving during stress exposure. Exp Clin Psychopharmacol. 2022 Oct;30(5):620-631. doi: 10.1037/pha0000458. Epub 2021 Apr 22.
PubMed 36102596Cummings JR, Tomiyama AJ, Ray LA. Does the Neuroimmune Modulator Ibudilast Alter Food Craving? Results in a Sample With Alcohol Use Disorder. J Addict Med. 2018 Sep/Oct;12(5):410-417. doi: 10.1097/ADM.0000000000000416.
PubMed 29794557
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Ibudilast as a Novel Treatment for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02025998
- Acronym / sponsor ID
- IBUD
- Conditions
- Alcohol Use Disorders
- Keywords
- ibudilast, alcoholism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- 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.
The objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders.
Detailed description
Alcohol dependence (AD) is a chronic and relapsing condition affecting 10 million Americans. To date, only four pharmacotherapies are approved by the FDA for the treatment of alcoholism and their efficacy is modest. Therefore, medication development for AD represents a high priority area. Ibudilast (IBUD) is a glial cell modulator that inhibits phosphodiesterases (PDE) -4 and -10 and macrophage migration inhibitory factor (MIF). Preclinical data suggest that neuroimmune modulation is critical to the rewarding properties of drugs of abuse, including alcohol. Further, IBUD has been shown to enhance GDNF release in vivo and GDNF modulation has been implicated in alcohol reinstatement in animals, while PDE inhibition has been shown to reduce alcohol intake in mice. Together, these findings suggest that neuroimmune modulation constitutes a novel target for the treatment of alcoholism. The objective of this study is to advance medication development for alcoholism by conducting an initial Phase II study of IBUD for AD. Specifically, the proposed study consists of a randomized, double-blind, placebo-controlled within-subject crossover design to determine the safety, tolerability, and initial human laboratory efficacy of IBUD in a sample of 24 non-treatment seeking individuals with either alcohol abuse or dependence treated with IBUD (50mg BID) and placebo. Participants will complete two separate 7-day inpatient stays at the UCLA CTRC during which they will take the study medication, complete an IV alcohol challenge, and take part in a stress-exposure and cue-exposure paradigms. Specific aims are to test whether IBUD (a) is safe in the context of alcohol administration, (b) attenuates alcohol-induced reinforcement, and (c) dampens stress-induced and cue-induced alcohol craving. In sum, this study will efficiently evaluate safety and initial efficacy of IBUD thereby screening novel medications for AD and elucidating potential mechanisms by which IBUD may be clinically efficacious. Results from this study will inform whether a randomized controlled trial of IBUD for alcoholism is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibudilast | Experimental | Drug: IbudilastIbudilast will be administered for 7 days at the target dose of 50 mg/bid |
| Sugar pill | Placebo comparator | Other: Matched placeboPlacebo pills will be administered for 7 days and taken twice daily |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 21 and 65
- meet DSM-IV diagnostic criteria for alcohol abuse or dependence
- report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment
Key exclusion criteria (11 listed)
- current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
- current (last 12 months) DSM-IV diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
- lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R);
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 |
|---|---|---|
| IbudilastAlso: MN-166, AV411Ibudilast is a glial cell modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor. | Drug | Ibudilast |
| Matched placeboAlso: Suggar pillA matched placebo (suggar pill) will be administered as a control condition. | Other | Sugar pill |
Primary outcome
Subjective response to alcohol
Time frame: During the alcohol administration and observation period which is expected to last a total of 4 hours
Biphasic Alcohol Effects Scale (BAES) Alcohol Urge Questionnaire (AUQ)
2 secondary outcomes
Stress-Induced Craving
Time frame: During the stress exposure and observation period which is expected to last a total of 2 hours
Cue-Induced Alcohol Craving
Time frame: During the cue-exposure and observation period which is expected to last a total of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 36102596Meredith LR, Green R, Grodin EN, Chorpita M, Miotto K, Ray LA. Ibudilast moderates the effect of mood on alcohol craving during stress exposure. Exp Clin Psychopharmacol. 2022 Oct;30(5):620-631. doi: 10.1037/pha0000458. Epub 2021 Apr 22.
- Derived from this study: PubMed 29794557Cummings JR, Tomiyama AJ, Ray LA. Does the Neuroimmune Modulator Ibudilast Alter Food Craving? Results in a Sample With Alcohol Use Disorder. J Addict Med. 2018 Sep/Oct;12(5):410-417. doi: 10.1097/ADM.0000000000000416.
- UCLA Addictions LaboratoryLink provided by the sponsor.
- 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.
Lara Ray, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibudilast in people with Alcohol Use Disorders, run by University of California, Los Angeles 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 3 inclusion and 11 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 23 Feb 2016. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective response to alcohol (time frame: During the alcohol administration and observation period which is expected to last a total of 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02025998, which also lists 2 linked publications.
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 23 Feb 2016.