ObesityPhase 4NCT00537810

Treatment of Binge Eating in Obese Patients in Primary Care

A Phase 4 study testing Sibutramine and Self-help CBT + Sibutramine in people with Obesity and Binge Eating, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Binge Eating
What is being tested?: Sibutramine and Self-help CBT + Sibutramine
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 3 sitesUnited States
Study dates: Sep 2007to Oct 2012
Phase: Phase 4
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Obese (BMI >= 30)

Who cannot join

Medication regimen that represents medical contraindication to sibutramine
Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
Pregnancy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Yale Internal Medicine Associates (YIMA)
New Haven, Connecticut, 06510
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
New Haven, Connecticut, 06510
Yale Psychiatric Research at Congress Place
New Haven, Connecticut, 06519

Other trials in United States

About this study

Conditions: Obesity, Binge Eating
Being tested: Sibutramine, Placebo, Self-help CBT + Sibutramine, Self-help CBT + Placebo
Keywords: Obesity, Binge eating, Sibutramine, Self-help, Primary care
Medical subject headings: Obesity, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SibutramineDrug
Also called Meridia
15 mg daily
PlaceboDrug
Daily
Self-help CBT + SibutramineBehavioural
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Self-help CBT + PlaceboBehavioural
Cognitive behavioral treatment manual for binge eating Placebo daily

Study groups in NCT00537810
Study group	Role	What they receive
Sibutramine	Experimental	Sibutramine 15 mg daily Receives: Drug: Sibutramine
Placebo	Placebo comparator	Placebo Daily Receives: Drug: Placebo
Placebo/CBTsh	Experimental	Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Receives: Behavioral: Self-help CBT + Sibutramine
Sibutramine/CBTsh	Experimental	Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Receives: Behavioral: Self-help CBT + Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Binge Eating (Remission)
Remission from binge eating (zero binge episodes during previous 28 days)
Measured: 4 months treatment; 6 and 12 month follow up post treatment
BMI
BMI (kg/m^2) was measured 4 months after treatment.
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Oct 2012

First posted1 Oct 2007 (estimated)
Study startSep 2007
Primary completionOct 2012
Study completionOct 2012

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 (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537810
Sponsor's protocol ID: 0501027352
Other IDs: R01DK073542-01A1
Status last verified: Aug 2021
First submitted: 27 Sep 2007
Last updated: 18 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.
PubMed 24857821
Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.
PubMed 26214545
Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
PubMed 25622201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Binge Eating in Obese Patients in Primary Care
ClinicalTrials.gov ID: NCT00537810
Acronym / sponsor ID: 0501027352
Conditions: Obesity, Binge Eating
Keywords: Obesity, Binge eating, Sibutramine, Self-help, Primary care
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Sep 2007
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 1 Oct 2007 (estimated)
Results: Posted 12 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sibutramine	Experimental	Drug: SibutramineSibutramine 15 mg daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo Daily
Placebo/CBTsh	Experimental	Behavioral: Self-help CBT + SibutraminePlacebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Sibutramine/CBTsh	Experimental	Behavioral: Self-help CBT + PlaceboSibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Obese (BMI >= 30)

Key exclusion criteria (3 listed)

Medication regimen that represents medical contraindication to sibutramine
Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
Pregnancy

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
SibutramineAlso: Meridia15 mg daily	Drug	Sibutramine
PlaceboDaily	Drug	Placebo
Self-help CBT + SibutramineCognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily	Behavioural	Placebo/CBTsh
Self-help CBT + PlaceboCognitive behavioral treatment manual for binge eating Placebo daily	Behavioural	Sibutramine/CBTsh

Primary outcome

Binge Eating (Remission)
Time frame: 4 months treatment; 6 and 12 month follow up post treatment
Remission from binge eating (zero binge episodes during previous 28 days)
BMI
Time frame: 4 months
BMI (kg/m^2) was measured 4 months after treatment.

Results and safety

Results posted to the registry on 12 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sibutramine	26	20
Placebo	27	14
Placebo/CBTsh	25	21
Sibutramine/CBTsh	26	22

Primary outcome: Binge Eating (Remission)

Time frame: 4 months treatment; 6 and 12 month follow up post treatment. Number. Unit: participants

Measure	Sibutramine n = 26	Placebo n = 27	Placebo/CBTsh n = 25	Sibutramine/CBTsh n = 26
Remission at Post-treatment	10 (11.4)	8 (9.9)	6 (7.6)	6 (8.0)
Remission at 6 month follow up	5	11	10	13
Remission at 12 month follow up	5	10	10	11

Sibutramine vs Placebo vs Placebo/CBTsh vs Sibutramine/CBTsh: p = 0.60, Chi-squared
Sibutramine vs Placebo vs Placebo/CBTsh vs Sibutramine/CBTsh: p = 0.13, Chi-squared
Sibutramine vs Placebo vs Placebo/CBTsh vs Sibutramine/CBTsh: p = 0.29, Chi-squared

Primary outcome: BMI

Time frame: 4 months. Mean (Standard Deviation). Unit: BMI (kg/m^2)

Measure	Sibutramine n = 21	Placebo n = 19	Placebo/CBTsh n = 22	Sibutramine/CBTsh n = 22
Value	38.4 (7.2)	39.6 (5.7)	35.9 (5.6)	35.6 (4.6)

Population analysed: Participants with complete data reported here (i.e., no imputation)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sibutramine	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
Placebo	0 of 27 (0%)	2 of 27 (7.4%)	Not reported
Placebo/CBTsh	0 of 25 (0%)	0 of 25 (0%)	Not reported
Sibutramine/CBTsh	0 of 26 (0%)	1 of 26 (3.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24857821Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.
Derived from this study: PubMed 26214545Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.
Derived from this study: PubMed 25622201Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.

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RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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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.

Carlos M. Grilo, PhD principal investigator

Yale University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sibutramine and Self-help CBT + Sibutramine in people with Obesity and Binge Eating, run by Yale University at 3 sites 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 1 inclusion and 3 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Dec 2014). 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 (Remission) (time frame: 4 months treatment; 6 and 12 month follow up post treatment). 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 NCT00537810, which also lists 3 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 18 Aug 2021.