CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Haloperidol +4 moredrug
Likely dose
Haloperidol 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02203786
NCT02203786Phase 2Completed

Comparative Effects of a D2 and Mixed D1-D2 Dopamine Antagonist on Gambling and Amphetamine Reinforcement in Pathological Gamblers and Healthy Controls

Centre for Addiction and Mental Health·interventional·Posted Jul 30, 2014·Updated Apr 25, 2016

In Brief

A Phase 2 clinical trial evaluating Haloperidol, Fluphenazine, and 3 other interventions for Pathological Gambling. Completed, enrolled 60 participants across 1 site.

Detailed Summary

To determine if: 1. pathological gambling is similar to psychostimulant addiction as reflected by parallel roles for D1 and D2 receptors in gambling and stimulant reinforcement. 2. these parallel roles are linked with gambling pathology or if they are evident in both gamblers and controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2014
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.9 years ago

Interventions

Haloperidoldrug

Dose/maximum dose = 3-mg; route = oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses). Dose 1: 3 visually identical capsules, each containing 1 mg haloperidol.

Fluphenazinedrug

Dose/maximum dose = 3-mg; route = oral. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses). Dose 1: 3 visually identical capsules, each containing 1 mg fluphenazine.

Dexedrinedrug

Dose/maximum dose = 20-mg; route = oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses. Dose 2: when participants reach expected peak blood levels for dose 1, they will receive their second dose. On sessions 3 and 4 (Phase II), the dose will consist of 2 visually identical capsules each containing 10 mg D-amphetamine.

Placebodrug

Dose 1: On alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing) participants will receive 3 visually identical placebo (lactose) capsules. Dose 2: when participants reach expected peak blood levels for dose 1, they will receive their second dose. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1.

Slot Machinebehavioral

15 minute play of a commercial slot machine game in bar-simulated laboratory setting.