Alcohol DependencePhase 1NCT01969617
Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
A Phase 1 study of Alcohol Dependence, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Alcohol Dependence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Oct 2014
- 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.
Who cannot join
- The subject is seeking treatment for alcohol dependence.
- The subject has had <6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
- The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) <4 weeks prior to the Screening Visit.
- The subject has >5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
- The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥10.
- The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene
- Conditions
- Alcohol Dependence
- Being tested
- Nalmefene 18 mg, then placebo, Placebo, then Nalmefene 18 mg
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene 18 mg, then placeboDrug
Also called Selincro®
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
Placebo, then Nalmefene 18 mgDrug
Also called Selincro®
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
| Study group | Role | What they receive |
|---|---|---|
| Nalmefene 18 mg, then placebo | Experimental | 18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride Receives: Drug: Nalmefene 18 mg, then placebo |
| Placebo, then Nalmefene 18 mg | Placebo comparator | 18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride Receives: Drug: Placebo, then Nalmefene 18 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
Measured: Day 1
Secondary outcomes (2)
Safety
Number of adverse events
Measured: Up to Day 8 and a 10-day safety follow up
Risk of suicidality
Columbia-Suicide Severity Rating Scale (CSSRS) score
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969617
- Sponsor's protocol ID
- 15660A
- Other IDs
- 2013-001154-98
- Status last verified
- Nov 2014
- First submitted
- 17 Oct 2013
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Quelch DR, Mick I, McGonigle J, Ramos AC, Flechais RSA, Bolstridge M, Rabiner E, Wall MB, Newbould RD, Steiniger-Brach B, van den Berg F, Boyce M, Ostergaard Nilausen D, Breuning Sluth L, Meulien D, von der Goltz C, Nutt D, Lingford-Hughes A. Nalmefene Reduces Reward Anticipation in Alcohol Dependence: An Experimental Functional Magnetic Resonance Imaging Study. Biol Psychiatry. 2017 Jun 1;81(11):941-948. doi: 10.1016/j.biopsych.2016.12.029. Epub 2017 Jan 10.
PubMed 28216062
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
- ClinicalTrials.gov ID
- NCT01969617
- Acronym / sponsor ID
- 15660A
- Conditions
- Alcohol Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- First posted
- 25 Oct 2013 (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.
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalmefene 18 mg, then placebo | Experimental | Drug: Nalmefene 18 mg, then placebo18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride |
| Placebo, then Nalmefene 18 mg | Placebo comparator | Drug: Placebo, then Nalmefene 18 mg18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.
Key exclusion criteria (7 listed)
- The subject is seeking treatment for alcohol dependence.
- The subject has had <6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
- The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) <4 weeks prior to the Screening Visit.
- The subject has >5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
- The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥10.
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 |
|---|---|---|
| Nalmefene 18 mg, then placeboAlso: Selincro®One single oral dose Nalmefene on Day 1 and Placebo on Day 8 | Drug | Nalmefene 18 mg, then placebo |
| Placebo, then Nalmefene 18 mgAlso: Selincro®One single oral dose Placebo on Day 1 and Nalmefene on Day 8 | Drug | Placebo, then Nalmefene 18 mg |
Primary outcome
Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
Time frame: Day 1
2 secondary outcomes
Safety
Time frame: Up to Day 8 and a 10-day safety follow up
Risk of suicidality
Time frame: Up to Day 8
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 11 Nov 2014.
- Derived from this study: PubMed 28216062Quelch DR, Mick I, McGonigle J, Ramos AC, Flechais RSA, Bolstridge M, Rabiner E, Wall MB, Newbould RD, Steiniger-Brach B, van den Berg F, Boyce M, Ostergaard Nilausen D, Breuning Sluth L, Meulien D, von der Goltz C, Nutt D, Lingford-Hughes A. Nalmefene Reduces Reward Anticipation in Alcohol Dependence: An Experimental Functional Magnetic Resonance Imaging Study. Biol Psychiatry. 2017 Jun 1;81(11):941-948. doi: 10.1016/j.biopsych.2016.12.029. Epub 2017 Jan 10.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
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 of Alcohol Dependence, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 1 inclusion and 7 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 11 Nov 2014. 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 Kingdom. 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?
Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task (time frame: Day 1). 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 NCT01969617, which also lists 1 linked publication.
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 Nov 2014.