ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.

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Detailed Description

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Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily at-home dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits over a 12-week study period. On an ongoing basis, subjects will complete a take-home binge diary designed to record the number of binge-eating episodes (binge episodes) and binge-eating days (binge days, days during which at least 1 binge occurred), as well as snacks and meals consumed daily over each 7-day period.

Conditions

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Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RDC-0313 (ALKS 33)

2-capsules taken orally

Group Type EXPERIMENTAL

RDC-0313 (ALKS 33)

Intervention Type DRUG

Capsules for daily oral administration

Placebo

2-capsules taken orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules containing lactose and no active drug for daily oral administration

Interventions

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RDC-0313 (ALKS 33)

Capsules for daily oral administration

Intervention Type DRUG

Placebo

Capsules containing lactose and no active drug for daily oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)
* Display greater than or equal to 3 binge eating days per week
* Body mass index (BMI) greater than or equal to 30 kg/m2
* Age of 18 years or older
* Women of childbearing potential must agree to use an approved method of birth control for the duration of the study

Exclusion Criteria

* Concurrent symptoms of bulimia nervosa or anorexia nervosa
* Suicidal ideation
* DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
* Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
* Women who are pregnant or breastfeeding
* Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
* Clinically unstable medical disease
* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* History of seizures, including clinically significant febrile seizures in childhood
* Current or anticipated need for prescribed opioid medication during the study period
* Use of any psychotropic medications (other than hypnotics)
* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No