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Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder

NCT03430180 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-07-16

No results posted yet for this study

Summary

Primary objective:

\*To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder

The secondary objectives of the study are:

* To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression
* To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder

Conditions

  • Pathological Gambling
  • Gambling Disorder
  • Opioid Antagonist
  • Naloxone

Interventions

DRUG

Naloxone hydrochloride

Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

DRUG

Placebo

One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.

Sponsors & Collaborators

  • Finnish Institute for Health and Welfare

    lead OTHER_GOV

Principal Investigators

  • Hannu Alho, Prof. · Finnish Institute for Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2019-08-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430180 on ClinicalTrials.gov