Investigation of Naltrexone for Pathological Gambling

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Center for Responsible Gaming
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT01057862
First received: January 25, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The investigators plan to investigate the safety, tolerability, and efficacy of the opioid antagonist naltrexone in Pathological Gambling. We hypothesize that naltrexone will be superior to placebo in reducing gambling urges and behavior, when combined with adjuvant non-pharmacological treatment as usual.


Condition Intervention Phase
Pathological Gambling
Drug: Naltrexone
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Investigation of Naltrexone for Pathological Gambling

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG) [ Time Frame: Weekly/bi-weekly visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Weekly/bi-weekly visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: February 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone Drug: Naltrexone
Targeted dosage of 50mg PO daily
Other Name: Naltrexone hydrochloride
Placebo Comparator: Placebo Other: Placebo
Sugar pills daily PO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women over age 18
  2. Current DSM-IV PG Diagnosis as determined by a score of ≥ 5A criteria and B criterion present on the SCI-PG and a score ≥ 5 on the SOGS
  3. Gambling behavior within 2 weeks prior to enrollment
  4. For women, stable use of a medically accepted form of contraception and negative results on urine pregnancy test at study onset
  5. Currently entering, enrolled, or interested in treatment for PG

Exclusion Criteria:

  1. Gambling that does not meet DSM-IV criteria for PG
  2. Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen
  3. Past or current acute hepatitis or liver failure
  4. History of renal impairment
  5. Current or recent (within one week) treatment with an opioid agonist/opioid analgesic or current opioid withdrawal
  6. Opiate agonist maintenance therapy (e.g. methadone)
  7. Known sensitivity to opioid antagonists
  8. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  9. A need for medication with unfavorable interactions with naltrexone
  10. Clinically significant suicidality
  11. Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by SCID
  12. Clinically significant cognitive impairment
  13. Previous treatment with naltrexone or nalmefene
  14. Treatment with investigational medication or depot neuroleptics within 3 months
  15. Lack of proficiency in written and spoken English
  16. Unable to travel to study sites for appointments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057862

Locations
United States, Connecticut
Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs
Middletown, Connecticut, United States, 06457
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Center for Responsible Gaming
Investigators
Principal Investigator: Marc N Potenza, M.D., Ph.D. Yale University
  More Information

Publications:

Responsible Party: Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University
ClinicalTrials.gov Identifier: NCT01057862     History of Changes
Other Study ID Numbers: 0901004667, NCRG CORE R09240
Study First Received: January 25, 2010
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Naltrexone
Pathological Gambling
Opioid Antagonist

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014