Trial Outcomes & Findings for Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment (NCT NCT03063606)

NCT ID: NCT03063606

Last Updated: 2024-02-01

Results Overview

Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 31 participants
• Primary outcome timeframe: Post-treatment (4 months)
• Results posted on: 2024-02-01

Participant Flow

This study is part of a larger RCT (NCT03045341). In this study, we randomized participants who were non-responders to acute treatment to receive either CBT or no CBT. They continued the pharmacotherapy from the earlier treatment. Because of this study design, we report results based on the primary aim of the study (CBT vs no CBT). Also because of this study design, we report adverse events that were systematically assessed as potentially related to the pharmacotherapy (not to CBT).

Participant milestones

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Overall Study STARTED	18	13
Overall Study COMPLETED	16	10
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment

Baseline characteristics by cohort

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n=18 Participants CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy n=13 Participants Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	Total n=31 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 13.6 • n=5 Participants	45.1 years STANDARD_DEVIATION 12.7 • n=7 Participants	46.3 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex/Gender, Customized Sex/Gender · Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex/Gender, Customized Sex/Gender · Transgender	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment (4 months)

Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.

Outcome measures

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n=15 Participants CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy n=10 Participants Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Binge Eating Frequency (Continuous)	0.8 Eating events/28 days Standard Deviation 1.6	12.1 Eating events/28 days Standard Deviation 9.9

PRIMARY outcome

Timeframe: Baseline and Post-treatment (4 months)

BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline

Outcome measures

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n=11 Participants CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy n=10 Participants Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Change in Body Mass Index at 4 Months Post-Treatment From Baseline	-0.16 Kg/m^2 Standard Deviation 4.27	-1.18 Kg/m^2 Standard Deviation 4.35

SECONDARY outcome

Timeframe: 6-Month Follow-up

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Outcome measures

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n=10 Participants CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy n=1 Participants Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Binge Eating Frequency (Continuous)	2.80 eating events/28 days Standard Deviation 6.56	3 eating events/28 days

SECONDARY outcome

Timeframe: 12-Month Follow-up

Population: No participants in the on-going blinded pharmacotherapy group completed the 12-month follow-up assessment.

Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

Outcome measures

Measure	Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy n=10 Participants CBT is a "specialist" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse. Cognitive-Behavioral Therapy (CBT): CBT specialist treatment NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)	On-going Blinded Pharmacotherapy Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy. NB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Binge Eating Frequency (Continuous)	1.70 eating events/28 days Standard Deviation 2.54	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-Month Follow-up

Population: There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.

BMI is calculated using measured height and weight (e.g., percent loss).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-Month Follow-up

Population: There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.

BMI is calculated using measured height and weight (e.g., percent loss).

Outcome measures

Outcome data not reported

Adverse Events

On-going Blinded Pharmacotherapy (NB)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

On-going Blinded Pharmacotherapy (Placebo)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	On-going Blinded Pharmacotherapy (NB) n=15 participants at risk On-going from acute treatment, consisting of naltrexone/bupropion combination	On-going Blinded Pharmacotherapy (Placebo) n=16 participants at risk On-going from acute treatment, consisting of placebo
Gastrointestinal disorders Constipation	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	6.2% 1/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	6.2% 1/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
Gastrointestinal disorders Nausea	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	12.5% 2/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	0.00% 0/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
General disorders Dizziness	0.00% 0/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	6.2% 1/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
General disorders Dry Mouth	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	6.2% 1/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
General disorders Headache	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	18.8% 3/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.
General disorders Insomnia	6.7% 1/15 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.	6.2% 1/16 • Month 1 Participants were interviewed for nonserious adverse events listed as \>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.

Additional Information

Dr. Carlos Grilo

Yale University

Phone: 203-785-7210

Email: carlos.grilo@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place