Investigation of Naltrexone for Pathological Gambling

NCT01057862 | Completed Phase 2 Results DMC

• 2 other identifiers: 0901004667NCRG CORE R09240
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pathological Gambling

Keywords

Naltrexone; Pathological Gambling; Opioid Antagonist

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)

  The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.

  Weekly/bi-weekly visits

Secondary Outcomes (1)

• Gambling Symptom Assessment Scale (G-SAS)

  Weekly/bi-weekly visits

Study Arms (2)

Naltrexone

EXPERIMENTAL

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Naltrexone DRUG

Targeted dosage of 50mg PO daily

Also known as: Naltrexone hydrochloride

Naltrexone

Placebo OTHER

Sugar pills daily PO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over age 18
• 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
• Gambling behavior within 2 weeks prior to enrollment
• For women, stable use of a medically accepted form of contraception and negative results on urine pregnancy test at study onset
• Currently entering, enrolled, or interested in treatment for PG

You may not qualify if:

• Gambling that does not meet DSM-IV criteria for PG
• Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen
• Past or current acute hepatitis or liver failure
• History of renal impairment
• Current or recent (within one week) treatment with an opioid agonist/opioid analgesic or current opioid withdrawal
• Opiate agonist maintenance therapy (e.g. methadone)
• Known sensitivity to opioid antagonists
• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
• A need for medication with unfavorable interactions with naltrexone
• Clinically significant suicidality
• Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by SCID
• Clinically significant cognitive impairment
• Previous treatment with naltrexone or nalmefene
• Treatment with investigational medication or depot neuroleptics within 3 months
• Lack of proficiency in written and spoken English

Sponsors & Collaborators

• Yale University: lead
• National Center for Responsible Gaming: collaborator

Study Sites (3)

Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs

Middletown, Connecticut, 06457, United States

Location

Connecticut DMHAS Problem Gambling Services and Bettor Choice Programs

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (9)

• Dannon PN, Lowengrub K, Gonopolski Y, Musin E, Kotler M. Pathological gambling: a review of phenomenological models and treatment modalities for an underrecognized psychiatric disorder. Prim Care Companion J Clin Psychiatry. 2006;8(6):334-9. doi: 10.4088/pcc.v08n0603.

  PMID: 17245454 BACKGROUND

• Grant JE, Kim SW, Hartman BK. A double-blind, placebo-controlled study of the opiate antagonist naltrexone in the treatment of pathological gambling urges. J Clin Psychiatry. 2008 May;69(5):783-9. doi: 10.4088/jcp.v69n0511.

  PMID: 18384246 BACKGROUND

• Grant JE, Potenza MN, Hollander E, Cunningham-Williams R, Nurminen T, Smits G, Kallio A. Multicenter investigation of the opioid antagonist nalmefene in the treatment of pathological gambling. Am J Psychiatry. 2006 Feb;163(2):303-12. doi: 10.1176/appi.ajp.163.2.303.

  PMID: 16449486 BACKGROUND

• Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9. doi: 10.1097/00004850-200109000-00006.

  PMID: 11552772 BACKGROUND

• Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21. doi: 10.1016/s0006-3223(01)01079-4.

  PMID: 11377409 BACKGROUND

• Melville KM, Casey LM, Kavanagh DJ. Psychological treatment dropout among pathological gamblers. Clin Psychol Rev. 2007 Dec;27(8):944-58. doi: 10.1016/j.cpr.2007.02.004. Epub 2007 Mar 2.

  PMID: 17433853 BACKGROUND

• Pallesen S, Mitsem M, Kvale G, Johnsen BH, Molde H. Outcome of psychological treatments of pathological gambling: a review and meta-analysis. Addiction. 2005 Oct;100(10):1412-22. doi: 10.1111/j.1360-0443.2005.01204.x.

  PMID: 16185203 BACKGROUND

• Pallesen S, Molde H, Arnestad HM, Laberg JC, Skutle A, Iversen E, Stoylen IJ, Kvale G, Holsten F. Outcome of pharmacological treatments of pathological gambling: a review and meta-analysis. J Clin Psychopharmacol. 2007 Aug;27(4):357-64. doi: 10.1097/jcp.013e3180dcc304d.

  PMID: 17632219 BACKGROUND

• Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.

  PMID: 36130734 DERIVED

MeSH Terms

Conditions

Gambling

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.

Results Point of Contact

• Title: Dr. Marc N Potenza
• Organization: Yale University

marc.potenza@yale.edu

2037373553

Study Officials

• Marc N Potenza, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 27, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 13, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-08

Locations

US (3)