Trial Outcomes & Findings for D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement (NCT NCT02203786)
NCT ID: NCT02203786
Last Updated: 2016-04-25
Results Overview
Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).
Results posted on
2016-04-25
Participant Flow
Recruitment was conducted for all groups between January 2010 and May 2015
Pathological Gamblers and healthy Controls were each randomized to receive Haloperidol or Fluphenazine. In each group, treatment sequence (antagonist first, placebo second; or vice versa) was counterbalanced across participants, to control for order effects only (sequence was not a test factor). Two Haloperidol-Controls dropped out after session 1.
Participant milestones
| Measure |
Haloperidol - Pathological Gamblers
Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.
Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses.
|
Fluphenazine - Pathological Gamblers
Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses.
|
Haloperidol - Controls
Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.
Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses.
|
Fluphenazine - Controls
Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
17
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement
Baseline characteristics by cohort
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 control subjects were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 control subjects were enrolled in this arm.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.8 years
n=5 Participants
|
33.5 years
n=7 Participants
|
36.1 years
n=5 Participants
|
39.9 years
n=4 Participants
|
36.3 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
South Oaks Gambling Screen (SOGS)
|
11.1 units on a scale
n=5 Participants
|
11.7 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=4 Participants
|
5.7 units on a scale
n=21 Participants
|
|
Beck Depression Inventory - past 2 weeks
|
4.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 4.5 • n=7 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants
|
3.02 units on a scale
STANDARD_DEVIATION 2.85 • n=21 Participants
|
|
Eysenck Impulsivity Scale
|
9.2 units on a scale
STANDARD_DEVIATION 4.4 • n=5 Participants
|
8.5 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 2.5 • n=4 Participants
|
5.47 units on a scale
STANDARD_DEVIATION 3.35 • n=21 Participants
|
|
Alcohol Dependence Scale
|
1.1 units on a scale
n=5 Participants
|
1.6 units on a scale
n=7 Participants
|
0.6 units on a scale
n=5 Participants
|
0.3 units on a scale
n=4 Participants
|
0.9 units on a scale
n=21 Participants
|
|
Timeline Followback
|
2.3 number of alcoholic drinks per week
n=5 Participants
|
1.5 number of alcoholic drinks per week
n=7 Participants
|
1.5 number of alcoholic drinks per week
n=5 Participants
|
1.8 number of alcoholic drinks per week
n=4 Participants
|
1.7 number of alcoholic drinks per week
n=21 Participants
|
PRIMARY outcome
Timeframe: At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Subjective Reinforcement Self-report Scales
Drug - Confidence not to gamble after slot machine
|
4.8 units on a scale
Standard Deviation 2.3
|
4.8 units on a scale
Standard Deviation 2.9
|
9.5 units on a scale
Standard Deviation 1.1
|
9.3 units on a scale
Standard Deviation 1
|
|
Subjective Reinforcement Self-report Scales
Placebo - Confidence not to gamble after slot mach
|
4.2 units on a scale
Standard Deviation 2.5
|
4.8 units on a scale
Standard Deviation 3.4
|
9 units on a scale
Standard Deviation 1.6
|
8.2 units on a scale
Standard Deviation 3.4
|
|
Subjective Reinforcement Self-report Scales
Drug - Confidence not to gamble at peak amphetamin
|
5.2 units on a scale
Standard Deviation 2.5
|
6.4 units on a scale
Standard Deviation 3.2
|
9.8 units on a scale
Standard Deviation 0.5
|
9.8 units on a scale
Standard Deviation 0.4
|
|
Subjective Reinforcement Self-report Scales
Plac -Confidence not to gamble at peak amphetamine
|
5.5 units on a scale
Standard Deviation 2.3
|
5.7 units on a scale
Standard Deviation 3.5
|
9.4 units on a scale
Standard Deviation 1.1
|
9.3 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
Drug-Change in DBP pre-to-post slot machine
|
20.2 mm Hg
Standard Deviation 24.5
|
22 mm Hg
Standard Deviation 23.6
|
15.1 mm Hg
Standard Deviation 18.6
|
23.6 mm Hg
Standard Deviation 23.8
|
|
Diastolic Blood Pressure (DBP)
Placebo-Change in DBP pre-to-post slot machine
|
22.5 mm Hg
Standard Deviation 24.8
|
21.6 mm Hg
Standard Deviation 29.3
|
19.1 mm Hg
Standard Deviation 24.8
|
19 mm Hg
Standard Deviation 23.4
|
|
Diastolic Blood Pressure (DBP)
Drug-Change in DBP pre-amphetamine to peak amph
|
27.2 mm Hg
Standard Deviation 24.4
|
32.1 mm Hg
Standard Deviation 25.1
|
28.5 mm Hg
Standard Deviation 30
|
32.7 mm Hg
Standard Deviation 30
|
|
Diastolic Blood Pressure (DBP)
Placebo-Change in DBP pre-amphetamine to peak amp
|
33.6 mm Hg
Standard Deviation 29.8
|
35.2 mm Hg
Standard Deviation 28
|
26.6 mm Hg
Standard Deviation 24.5
|
36.3 mm Hg
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience)
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Cognitive Task Performance
post-slots-GAM words under drug
|
91.6 percentage of neutral categorized words
Standard Deviation 7.9
|
94.0 percentage of neutral categorized words
Standard Deviation 6.0
|
94.8 percentage of neutral categorized words
Standard Deviation 6.1
|
91.0 percentage of neutral categorized words
Standard Deviation 7.9
|
|
Cognitive Task Performance
post-slots-ALC words under drug
|
95.5 percentage of neutral categorized words
Standard Deviation 8.4
|
98.1 percentage of neutral categorized words
Standard Deviation 7.6
|
96.5 percentage of neutral categorized words
Standard Deviation 6.6
|
93.1 percentage of neutral categorized words
Standard Deviation 8.9
|
|
Cognitive Task Performance
post-slots POS words under drug
|
91.3 percentage of neutral categorized words
Standard Deviation 8.7
|
95.3 percentage of neutral categorized words
Standard Deviation 7.6
|
93.7 percentage of neutral categorized words
Standard Deviation 8.3
|
88.3 percentage of neutral categorized words
Standard Deviation 8.4
|
|
Cognitive Task Performance
post-slots NEG words under drug
|
89.1 percentage of neutral categorized words
Standard Deviation 9.5
|
96.5 percentage of neutral categorized words
Standard Deviation 7.3
|
89.6 percentage of neutral categorized words
Standard Deviation 7.6
|
87.9 percentage of neutral categorized words
Standard Deviation 10.2
|
|
Cognitive Task Performance
post-slots GAM words under placebo
|
91.6 percentage of neutral categorized words
Standard Deviation 8.1
|
95.0 percentage of neutral categorized words
Standard Deviation 5.3
|
97.2 percentage of neutral categorized words
Standard Deviation 7.2
|
92.1 percentage of neutral categorized words
Standard Deviation 5.3
|
|
Cognitive Task Performance
post-slots ALC words under placebo
|
94.8 percentage of neutral categorized words
Standard Deviation 6.1
|
99.0 percentage of neutral categorized words
Standard Deviation 7.2
|
97.0 percentage of neutral categorized words
Standard Deviation 6.5
|
93.3 percentage of neutral categorized words
Standard Deviation 4.7
|
|
Cognitive Task Performance
post-slots POS words under placebo
|
92.7 percentage of neutral categorized words
Standard Deviation 8.1
|
94.9 percentage of neutral categorized words
Standard Deviation 5.8
|
93.7 percentage of neutral categorized words
Standard Deviation 6.1
|
86.8 percentage of neutral categorized words
Standard Deviation 10.3
|
|
Cognitive Task Performance
post-slots NEG words under placebo
|
93.0 percentage of neutral categorized words
Standard Deviation 10.4
|
97.2 percentage of neutral categorized words
Standard Deviation 13.4
|
92.3 percentage of neutral categorized words
Standard Deviation 4.8
|
84.7 percentage of neutral categorized words
Standard Deviation 6.7
|
|
Cognitive Task Performance
peak AMPH GAM words under drug
|
96.7 percentage of neutral categorized words
Standard Deviation 3.4
|
95.8 percentage of neutral categorized words
Standard Deviation 4.5
|
98.1 percentage of neutral categorized words
Standard Deviation 4.5
|
97.0 percentage of neutral categorized words
Standard Deviation 5.9
|
|
Cognitive Task Performance
peak AMPH ALC words under drug
|
101.2 percentage of neutral categorized words
Standard Deviation 3.6
|
99.5 percentage of neutral categorized words
Standard Deviation 4.6
|
99.1 percentage of neutral categorized words
Standard Deviation 3.9
|
100.3 percentage of neutral categorized words
Standard Deviation 5.4
|
|
Cognitive Task Performance
peak AMPH POS words under drug
|
98.2 percentage of neutral categorized words
Standard Deviation 3.3
|
98.7 percentage of neutral categorized words
Standard Deviation 4.6
|
97.2 percentage of neutral categorized words
Standard Deviation 4.7
|
96.3 percentage of neutral categorized words
Standard Deviation 4.7
|
|
Cognitive Task Performance
peak AMPH NEG words under drug
|
99.5 percentage of neutral categorized words
Standard Deviation 5.1
|
99.4 percentage of neutral categorized words
Standard Deviation 4.8
|
96.8 percentage of neutral categorized words
Standard Deviation 3.6
|
98.7 percentage of neutral categorized words
Standard Deviation 5.2
|
|
Cognitive Task Performance
peak AMPH GAM words under placebo
|
95.0 percentage of neutral categorized words
Standard Deviation 4.9
|
97.9 percentage of neutral categorized words
Standard Deviation 5.8
|
96.8 percentage of neutral categorized words
Standard Deviation 2.9
|
96.9 percentage of neutral categorized words
Standard Deviation 5.3
|
|
Cognitive Task Performance
peak AMPH ALC words under placebo
|
99.9 percentage of neutral categorized words
Standard Deviation 6.2
|
99.9 percentage of neutral categorized words
Standard Deviation 5.3
|
100.2 percentage of neutral categorized words
Standard Deviation 4.7
|
97.5 percentage of neutral categorized words
Standard Deviation 6.5
|
|
Cognitive Task Performance
peak AMPH POS words under placebo
|
98.4 percentage of neutral categorized words
Standard Deviation 4.7
|
97.7 percentage of neutral categorized words
Standard Deviation 5.5
|
97.8 percentage of neutral categorized words
Standard Deviation 4.0
|
95.1 percentage of neutral categorized words
Standard Deviation 3.3
|
|
Cognitive Task Performance
peak AMPH NEG words under placebo
|
99.0 percentage of neutral categorized words
Standard Deviation 6.5
|
100.0 percentage of neutral categorized words
Standard Deviation 3.4
|
98.1 percentage of neutral categorized words
Standard Deviation 5.7
|
96.7 percentage of neutral categorized words
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Betting Behaviour in Laboratory-based Slot Machine Game
Mean bet under placebo
|
10.4 credits/spin on slot machine
Standard Deviation 9.3
|
16.1 credits/spin on slot machine
Standard Deviation 12.4
|
9.5 credits/spin on slot machine
Standard Deviation 10.8
|
12.2 credits/spin on slot machine
Standard Deviation 9.5
|
|
Betting Behaviour in Laboratory-based Slot Machine Game
Mean bet under drug
|
12.8 credits/spin on slot machine
Standard Deviation 7.2
|
16.0 credits/spin on slot machine
Standard Deviation 10.4
|
11.6 credits/spin on slot machine
Standard Deviation 7.8
|
14.4 credits/spin on slot machine
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: 15-minutesNumber of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Speed of Play on Slot Machine Game
Spins/15-minutes under Drug
|
76.9 individual spins/15-minutes
Standard Deviation 35.4
|
78.5 individual spins/15-minutes
Standard Deviation 34.5
|
66.4 individual spins/15-minutes
Standard Deviation 27.9
|
71.8 individual spins/15-minutes
Standard Deviation 30.5
|
|
Speed of Play on Slot Machine Game
Spins/15-minutes under Placebo
|
88.6 individual spins/15-minutes
Standard Deviation 32.9
|
68.4 individual spins/15-minutes
Standard Deviation 47.3
|
72.2 individual spins/15-minutes
Standard Deviation 40.5
|
66.7 individual spins/15-minutes
Standard Deviation 31.6
|
SECONDARY outcome
Timeframe: 15-minutesCredits
Outcome measures
| Measure |
Haloperidol - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Fluphenazine - Pathological Gamblers
n=15 Participants
A total of 15 pathological gamblers were enrolled in this arm.
|
Haloperidol - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
Fluphenazine - Controls
n=15 Participants
A total of 15 controls were enrolled in this arm.
|
|---|---|---|---|---|
|
Winnings on Slot Machine Upon Completion of Game
Winnings (Final Credit Tally) under drug
|
239 credits
Standard Deviation 305.1
|
277.8 credits
Standard Deviation 300.2
|
449.1 credits
Standard Deviation 669.6
|
544.3 credits
Standard Deviation 820
|
|
Winnings on Slot Machine Upon Completion of Game
Winnings (Final Credit Tally) under Placebo
|
562.4 credits
Standard Deviation 658
|
140.8 credits
Standard Deviation 325.7
|
339.2 credits
Standard Deviation 427.4
|
215 credits
Standard Deviation 214.8
|
Adverse Events
Haloperidol - Pathological Gamblers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluphenazine - Pathological Gamblers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Haloperidol - Controls
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fluphenazine - Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Haloperidol - Pathological Gamblers
n=15 participants at risk
Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).
Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses.
|
Fluphenazine - Pathological Gamblers
n=15 participants at risk
Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).
Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses.
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Haloperidol - Controls
n=15 participants at risk
Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).
Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).
Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses.
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Fluphenazine - Controls
n=15 participants at risk
Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).
Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.
Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses.
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Nervous system disorders
Akathisia
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0.00%
0/15 • Same day as drug administration
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0.00%
0/15 • Same day as drug administration
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13.3%
2/15 • Number of events 2 • Same day as drug administration
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0.00%
0/15 • Same day as drug administration
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Additional Information
Dr. Daniela Lobo, Qualified Investigator for Study, Clinician-Scientist
Centre for Addiction and Mental Health
Phone: 416-535-8501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place