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Treatment of Binge Eating in Obese Patients in Primary Care

Treatment of Binge Eating in Obese Patients in Primary Care

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00537810
Enrollment
104
Registered
2007-10-01
Start date
2007-09-30
Completion date
2012-10-31
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating, Obesity

Keywords

Obesity, Binge eating, Sibutramine, Self-help, Primary care

Brief 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. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.

Interventions

DRUGSibutramine

15 mg daily

DRUGPlacebo

Daily

BEHAVIORALSelf-help CBT + Sibutramine

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

BEHAVIORALSelf-help CBT + Placebo

Cognitive behavioral treatment manual for binge eating Placebo daily

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Obese (BMI \>= 30)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Binge Eating (Remission)4 months treatment; 6 and 12 month follow up post treatmentRemission from binge eating (zero binge episodes during previous 28 days)
BMI4 monthsBMI (kg/m\^2) was measured 4 months after treatment.

Countries

United States

Participant flow

Participants by arm

ArmCount
Sibutramine
Sibutramine 15 mg daily Sibutramine: 15 mg daily
26
Placebo
Placebo Daily Placebo: Daily
27
Placebo/CBTsh
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
25
Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily
26
Total104

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyMedically withdrawn2201
Overall StudyWithdrawal by Subject41143

Baseline characteristics

CharacteristicTotalSibutramine/CBTshPlacebo/CBTshPlaceboSibutramine
Age at onset of Binge Eating Disorder (BED)26.2 years
STANDARD_DEVIATION 12.5
29.1 years
STANDARD_DEVIATION 13.1
25.7 years
STANDARD_DEVIATION 15.1
25.5 years
STANDARD_DEVIATION 11.1
25.7 years
STANDARD_DEVIATION 11.2
Age, Continuous44.2 years
STANDARD_DEVIATION 11.1
45.6 years
STANDARD_DEVIATION 9.4
45.7 years
STANDARD_DEVIATION 12.4
43.2 years
STANDARD_DEVIATION 12.4
41.2 years
STANDARD_DEVIATION 10.3
Race/Ethnicity, Customized
African-American
36 participants10 participants6 participants12 participants8 participants
Race/Ethnicity, Customized
Caucasian
47 participants10 participants12 participants12 participants13 participants
Race/Ethnicity, Customized
Hispanic-American
14 participants4 participants4 participants2 participants4 participants
Race/Ethnicity, Customized
Other
7 participants2 participants3 participants1 participants1 participants
Sex: Female, Male
Female
73 Participants16 Participants20 Participants18 Participants19 Participants
Sex: Female, Male
Male
31 Participants10 Participants5 Participants9 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
1 / 262 / 270 / 251 / 26
serious
Total, serious adverse events
0 / 260 / 270 / 250 / 26

Outcome results

Primary

Binge Eating (Remission)

Remission from binge eating (zero binge episodes during previous 28 days)

Time frame: 4 months treatment; 6 and 12 month follow up post treatment

ArmMeasureGroupValue (NUMBER)Dispersion
SibutramineBinge Eating (Remission)Remission at Post-treatment10 participants 11.4
SibutramineBinge Eating (Remission)Remission at 12 month follow up5 participants—
SibutramineBinge Eating (Remission)Remission at 6 month follow up5 participants—
PlaceboBinge Eating (Remission)Remission at Post-treatment8 participants 9.9
PlaceboBinge Eating (Remission)Remission at 12 month follow up10 participants—
PlaceboBinge Eating (Remission)Remission at 6 month follow up11 participants—
Placebo/CBTshBinge Eating (Remission)Remission at 6 month follow up10 participants—
Placebo/CBTshBinge Eating (Remission)Remission at Post-treatment6 participants 7.6
Placebo/CBTshBinge Eating (Remission)Remission at 12 month follow up10 participants—
Sibutramine/CBTshBinge Eating (Remission)Remission at Post-treatment6 participants 8
Sibutramine/CBTshBinge Eating (Remission)Remission at 12 month follow up11 participants—
Sibutramine/CBTshBinge Eating (Remission)Remission at 6 month follow up13 participants—
Comparison: Post-treatmentp-value: 0.6Chi-squared
Comparison: 6 month follow upp-value: 0.13Chi-squared
Comparison: 12 month follow upp-value: 0.29Chi-squared
Primary

BMI

BMI (kg/m\^2) was measured 4 months after treatment.

Time frame: 4 months

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

ArmMeasureValue (MEAN)Dispersion
SibutramineBMI38.4 BMI (kg/m^2)Standard Deviation 7.2
PlaceboBMI39.6 BMI (kg/m^2)Standard Deviation 5.7
Placebo/CBTshBMI35.9 BMI (kg/m^2)Standard Deviation 5.6
Sibutramine/CBTshBMI35.6 BMI (kg/m^2)Standard Deviation 4.6

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026