NCT01625611

Brief Summary

The primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has been approved for the treatment of alcohol dependence. Receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking behavior. This study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. We will use PET (positron emission tomography) for this study. PET is a type of imaging device found in nuclear medicine. It is used for tracking the presence of injected radioactive materials in the body.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

10.4 years

First QC Date

June 19, 2012

Results QC Date

May 23, 2022

Last Update Submit

August 8, 2022

Conditions

Alcohol Drinking

Keywords

AlcoholDrinkingDrinkersAlcohol DrinkingNaltrexoneAlcohol DependenceAlcohol AbuseAlcohol-Related DisordersEthanolAlcoholism

Outcome Measures

Primary Outcomes (2)

  • Occupancy of KOR by NTX and Drinking

    To determine the degree to which occupancy of KORs by a 100 mg/day dose of NTX mediates (influences the strength of) responsivity to NTX treatment in all heavy drinkers.

    6-8 days after treatment with naltrexone

  • Relationship Between NTX Responsivity and Occupancy of KOR

    To determine whether the relationship between NTX responsivity and occupancy of KOR is different in family history positive vs. family history negative heavy drinkers. Evaluations were done with a logistic regression which included years of drinking (a covariate), family history status, and occupancy of KOR. The logistic model calculated a probability of response, defined as a 50% or greater reduction in drinking after naltrexone, for every participant. Reported outcome is the area under the ROC produced by the model. The closer the value is to 100 percent probability, the better the model is at correctly classifying the observations.

    6-8 days after treatment with naltrexone

Secondary Outcomes (1)

  • Baseline KOR Differences

    at baseline prior to treatment with naltrexone

Study Arms (1)

Naltrexone

EXPERIMENTAL
Drug: Naltrexone

Interventions

NaltrexoneDRUG

Naltrexone 100 mg titrated over one week

Also known as: Revia
Naltrexone

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 21-50
  • Able to read English at 6th grade level or higher and to complete study evaluations
  • Regular alcohol drinker

You may not qualify if:

  • Individuals who are seeking alcohol treatment
  • Medical conditions that would contraindicate the use of study medication
  • Regular use of other substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sac, Cmhc

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • de Laat B, Goldberg A, Shi J, Tetrault JM, Nabulsi N, Zheng MQ, Najafzadeh S, Gao H, Kapinos M, Ropchan J, O'Malley SS, Huang Y, Morris ED, Krishnan-Sarin S. The Kappa Opioid Receptor Is Associated With Naltrexone-Induced Reduction of Drinking and Craving. Biol Psychiatry. 2019 Dec 1;86(11):864-871. doi: 10.1016/j.biopsych.2019.05.021. Epub 2019 Jun 8.

    PMID: 31399255DERIVED

MeSH Terms

Conditions

Alcohol DrinkingAlcoholismAlcohol-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Krishnan-Sarin
Organization
Yale University
nicholas.franco@yale.edu
203.974.7595

Study Officials

  • Suchitra Krishnan-Sarin, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

February 1, 2011

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 10, 2022

Results First Posted

August 10, 2022

Record last verified: 2022-08

Locations

US(1)