AlcoholismPhase 2NCT01362699
Effect of JNJ 31001074 on Urge to Drink in Alcohol-Dependent Adults
A Phase 2 study testing JNJ-31001074 in people with Alcoholism, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment. Read more about this study
- Who is it for?
- Ages 21 to 62 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- JNJ-31001074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2012
- 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 21 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Currently alcohol dependent but not seeking treatment
- Meets study criteria for amount of alcohol consumed
- Otherwise healthy
- Urge to drink increased by the presence of alcohol
- Able to complete and understand questionnaires and study procedures in English
- Willing and able to comply with the study requirements, including a 3-day period of alcohol abstinence and use of highly effective contraceptive methods
- Signed informed consent.
Who cannot join
- Pregnant or breast-feeding
- Significant medical or psychiatric conditions other than alcohol dependence
- History of, or at risk of, medically significant alcohol withdrawal syndrome
- Dependent on substances other than alcohol , nicotine or caffeine
- Smokes more than 1 pack of cigarettes per day or consumes more than 500 mg caffeine per day
- Has glaucoma, cataracts, a history of eye inflammation, eye injury, or eye surgery other than to correct vision
- Treatment in the past 1 month prior to screening with disulfiram (Antabuse), acamprosate (Campral), naltrexone (ReVia or Vivitrol), or topiramate (Topamax)
- In need of or currently taking any psychoactive medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy of JNJ 31001074 on Cue Induced Craving for Alcohol in Adult Subjects With Alcohol DependenceH3 Alcoholism
The purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.
Read the detailed description
This study will evaluate whether JNJ 31001074 reduces the urge to drink alcohol in non treatment seeking, adult study participants with current alcohol dependence. Individuals who meet criteria for study participation will be randomly assigned to one of two treatment groups (tablets containing JNJ 31001074 or placebo tablets with no active ingredients) in a 1:1 ratio. Treatment group assignment will not be known by study participants or study staff. Baseline assessments will be recorded and participants will return to the clinic for testing on the last day of taking their assigned study medication for 7 days at home. Alcohol use is not allowed for 3 days prior to this end-of-dosing testing. During this test, their urge to drink alcohol and their mood will be measured while they view various computer images and then are presented with (but do not drink) either a favorite alcoholic beverage or water. Other measures will be collected during the study to evaluate the safety and tolerability of the study medication, including potential effects on sleep, as well as measures of thinking and cigarette smoking. Participants will return for a follow-up visit approximately 1 week after finishing the study medication and completing the clinic assessment above. Study participants will take one 3-mg tablet of JNJ-31001074 or matching placebo in the morning, preferably with food, for 7 days.
- Conditions
- Alcoholism
- Being tested
- JNJ-31001074, Placebo
- Keywords
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Alcohol Dependence, JNJ-31001074, Bavisant
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-31001074Drug
Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.
PlaceboDrug
Form=tablet, route=oral administration. One tablet once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-31001074 | Experimental | Not described Receives: Drug: JNJ-31001074 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urge to drink
Measured: 1 week
Secondary outcomes (5)
The number of patients reporting adverse events as a measure of safety and tolerability
Measured: Up to approximately 15 days
Abnormal findings from eye exams performed as a measure of safety and tolerability
Measured: Up to approximately 8-15 days
Vital signs measurements as a measure of safety and tolerability
Measured: Up to approximately 15 days
Electrocardiograms as a measure of safety and tolerability
Measured: Up to approximately 15 days
Clinical Laboratory tests as a measure of safety and tolerability
Measured: Up to approximately 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startAug 2011
- Study completionAug 2012 (estimated)
Why it stopped: Re-prioritization lead to study cancellation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Scripps Research Institute
- Investigators
- Janssen Research & Development, LLC C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362699
- Sponsor's protocol ID
- CR018802
- Other IDs
- 31001074ALC2001
- Status last verified
- Apr 2012
- First submitted
- 19 May 2011
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Efficacy of JNJ 31001074 on Cue Induced Craving for Alcohol in Adult Subjects With Alcohol DependenceH3 Alcoholism
- ClinicalTrials.gov ID
- NCT01362699
- Acronym / sponsor ID
- CR018802
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Alcohol Dependence, JNJ-31001074, Bavisant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Re-prioritization lead to study cancellation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Scripps Research Institute
- Study start
- Aug 2011
- Study completion
- Aug 2012 (estimated)
- First posted
- 30 May 2011 (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 purpose of this study is to assess whether JNJ-31001074 taken for 7 days reduces the urge to drink alcohol in alcohol-dependent study participants who are not seeking treatment.
Detailed description
This study will evaluate whether JNJ 31001074 reduces the urge to drink alcohol in non treatment seeking, adult study participants with current alcohol dependence. Individuals who meet criteria for study participation will be randomly assigned to one of two treatment groups (tablets containing JNJ 31001074 or placebo tablets with no active ingredients) in a 1:1 ratio. Treatment group assignment will not be known by study participants or study staff. Baseline assessments will be recorded and participants will return to the clinic for testing on the last day of taking their assigned study medication for 7 days at home. Alcohol use is not allowed for 3 days prior to this end-of-dosing testing. During this test, their urge to drink alcohol and their mood will be measured while they view various computer images and then are presented with (but do not drink) either a favorite alcoholic beverage or water. Other measures will be collected during the study to evaluate the safety and tolerability of the study medication, including potential effects on sleep, as well as measures of thinking and cigarette smoking. Participants will return for a follow-up visit approximately 1 week after finishing the study medication and completing the clinic assessment above. Study participants will take one 3-mg tablet of JNJ-31001074 or matching placebo in the morning, preferably with food, for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-31001074 | Experimental | Drug: JNJ-31001074 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female
- Currently alcohol dependent but not seeking treatment
- Meets study criteria for amount of alcohol consumed
- Otherwise healthy
- Urge to drink increased by the presence of alcohol
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding
- Significant medical or psychiatric conditions other than alcohol dependence
- History of, or at risk of, medically significant alcohol withdrawal syndrome
- Dependent on substances other than alcohol , nicotine or caffeine
- Smokes more than 1 pack of cigarettes per day or consumes more than 500 mg caffeine per day
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 |
|---|---|---|
| JNJ-31001074Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days. | Drug | JNJ-31001074 |
| PlaceboForm=tablet, route=oral administration. One tablet once daily for 7 days. | Drug | Placebo |
Primary outcome
Urge to drink
Time frame: 1 week
5 secondary outcomes
The number of patients reporting adverse events as a measure of safety and tolerability
Time frame: Up to approximately 15 days
Abnormal findings from eye exams performed as a measure of safety and tolerability
Time frame: Up to approximately 8-15 days
Vital signs measurements as a measure of safety and tolerability
Time frame: Up to approximately 15 days
Electrocardiograms as a measure of safety and tolerability
Time frame: Up to approximately 15 days
Clinical Laboratory tests as a measure of safety and tolerability
Time frame: Up to approximately 8 days
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 30 Apr 2012.
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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.
Janssen Research & Development, LLC C. Clinical Trial study director
Janssen Research & Development, LLC
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 JNJ-31001074 in people with Alcoholism, run by Janssen Research & Development, LLC 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 8 inclusion and 8 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 30 Apr 2012. 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?
Urge to drink (time frame: 1 week). 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 30 Apr 2012.