Binge Eating DisorderNCT02317744
Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
A study testing Naltrexone and bupropion combination in people with Binge Eating Disorder, run by Yale University at 1 site in United States.
Trial summary
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Naltrexone and bupropion combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Sep 2016
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- BMI between 30 kg/m2 and 50 kg/m2
- Not taking anti-depressant medications
- Read English proficiently enough to read study assessments
- Available for duration of treatment plus follow-up period
- Able to travel to study location (New Haven, CT) for monthly visits
- Agree to study procedures
Who cannot join
- Medical status judged by study physician as contraindication
- History of seizures
- Past or current anorexia nervosa, bulimia nervosa
- Current medications that influence eating/weight
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.
- Conditions
- Binge Eating Disorder
- Being tested
- Naltrexone and bupropion combination, Pill Placebo
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and bupropion combinationDrug
Pill PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone/ Bupropion combination | Experimental | 50 mg naltrexone and 300 mg bupropion per day for 3 months Receives: Drug: Naltrexone and bupropion combination |
| Pill placebo | Placebo comparator | Daily placebo medication for 3 months Receives: Other: Pill Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Measured: Post-treatment (at 3 months)
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Measured: 6 month follow-up (an average of 6 months following treatment)
Secondary outcomes (2)
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Measured: Post-treatment (at 3 months)
Body Mass Index (BMI)
BMI is calculated using measured height and weight.
Measured: 6 month follow-up (an average of 6 months following treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos M Grilo, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317744
- Sponsor's protocol ID
- 1409014705
- Status last verified
- Nov 2017
- First submitted
- 11 Dec 2014
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.
PubMed 33218742
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
- ClinicalTrials.gov ID
- NCT02317744
- Acronym / sponsor ID
- 1409014705
- Conditions
- Binge Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone/ Bupropion combination | Experimental | Drug: Naltrexone and bupropion combination50 mg naltrexone and 300 mg bupropion per day for 3 months |
| Pill placebo | Placebo comparator | Other: Pill PlaceboDaily placebo medication for 3 months |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- BMI between 30 kg/m2 and 50 kg/m2
- Not taking anti-depressant medications
- Read English proficiently enough to read study assessments
- Available for duration of treatment plus follow-up period
Key exclusion criteria (6 listed)
- Medical status judged by study physician as contraindication
- History of seizures
- Past or current anorexia nervosa, bulimia nervosa
- Current medications that influence eating/weight
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
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 |
|---|---|---|
| Naltrexone and bupropion combination | Drug | Naltrexone/ Bupropion combination |
| Pill Placebo | Other | Pill placebo |
Primary outcome
Binge Eating Frequency (Continuous)
Time frame: Post-treatment (at 3 months)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
Binge Eating Frequency (Continuous)
Time frame: 6 month follow-up (an average of 6 months following treatment)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
2 secondary outcomes
Body Mass Index (BMI)
Time frame: Post-treatment (at 3 months)
Body Mass Index (BMI)
Time frame: 6 month follow-up (an average of 6 months following treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33218742Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.
Related trials for Binge Eating Disorder
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
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.
Carlos M Grilo, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone and bupropion combination in people with Binge Eating Disorder, run by Yale University 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 7 inclusion and 6 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 22 Dec 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2017). 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?
Binge Eating Frequency (Continuous) (time frame: Post-treatment (at 3 months)). 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?
On the ClinicalTrials.gov record for NCT02317744, 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 22 Dec 2017.