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D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement (HFDEX)

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ClinicalTrials.gov Identifier: NCT02203786
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Daniela Lobo, Centre for Addiction and Mental Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Pathological Gambling
Interventions Drug: Haloperidol
Drug: Fluphenazine
Drug: Dexedrine
Drug: Placebo
Behavioral: Slot Machine
Enrollment 60
Recruitment Details Recruitment was conducted for all groups between January 2010 and May 2015
Pre-assignment Details 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.
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 15 15 17 15
Completed 15 15 15 15
Not Completed 0 0 2 0
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls Total
Hide Arm/Group Description A total of 15 pathological gamblers were enrolled in this arm. A total of 15 pathological gamblers were enrolled in this arm. A total of 15 control subjects were enrolled in this arm. A total of 15 control subjects were enrolled in this arm. Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 15 60
Hide Baseline Analysis Population Description
All participants were above 18 years of age.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
35.8
(22 to 53)
33.5
(19 to 49)
36.1
(19 to 56)
39.9
(23 to 62)
36.3
(19 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
Female
5
  33.3%
4
  26.7%
5
  33.3%
7
  46.7%
21
  35.0%
Male
10
  66.7%
11
  73.3%
10
  66.7%
8
  53.3%
39
  65.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
1
   6.7%
1
   6.7%
1
   6.7%
4
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   1.7%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  20.0%
3
  20.0%
2
  13.3%
3
  20.0%
11
  18.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
  73.3%
11
  73.3%
11
  73.3%
11
  73.3%
44
  73.3%
South Oaks Gambling Screen (SOGS)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
11.1
(6 to 18)
11.7
(5 to 20)
0
(0 to 0)
0
(0 to 0)
5.7
(0 to 20)
[1]
Measure Description: Range of possible scores on the SOGS is 0-20. A score of 5 or more indicates "probable pathological gambling" with respect to DSM criteria.
Beck Depression Inventory - past 2 weeks   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
4.3  (3.6) 5.6  (4.5) 0.9  (1.2) 1.3  (2.1) 3.02  (2.85)
[1]
Measure Description: Measure of depressive symptoms in the past 2 weeks. The scale contains 13 items scored 0-3 in increasing severity (range of possible scores: 0-39). A score of 10 is considered the cut-off for clinically relevant depressive symptoms.
Eysenck Impulsivity Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
9.2  (4.4) 8.5  (4.4) 2.6  (2.1) 1.6  (2.5) 5.47  (3.35)
[1]
Measure Description: This 19-item yes/no scale measures trait impulsivity. Scores range from 0-19. The normative mean in the general population is 9. The mean score in large samples of people with pathological gambling is also 9.
Alcohol Dependence Scale   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
1.1
(0 to 4)
1.6
(0 to 11)
0.6
(0 to 3)
0.3
(0 to 4)
0.9
(0 to 11)
[1]
Measure Description: This 25-item scale assesses severity of the Alcohol Dependence syndrome. Total scores range from 0-51. A score of 13 corresponds to the 1st quartile and scores from 0-13 are said to indicate low dependence. A score of 9 or more has been associated with alcohol "abuse."
Timeline Followback   [1] 
Mean (Full Range)
Unit of measure:  Number of alcoholic drinks per week
Number Analyzed 15 participants 15 participants 15 participants 15 participants 60 participants
2.3
(0 to 8)
1.5
(0 to 3)
1.5
(0 to 6)
1.8
(0 to 5.5)
1.7
(0 to 8)
[1]
Measure Description: number of alcoholic drinks per week
1.Primary Outcome
Title Subjective Reinforcement Self-report Scales
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Drug - Confidence not to gamble after slot machine 4.8  (2.3) 4.8  (2.9) 9.5  (1.1) 9.3  (1)
Placebo - Confidence not to gamble after slot mach 4.2  (2.5) 4.8  (3.4) 9  (1.6) 8.2  (3.4)
Drug - Confidence not to gamble at peak amphetamin 5.2  (2.5) 6.4  (3.2) 9.8  (0.5) 9.8  (0.4)
Plac -Confidence not to gamble at peak amphetamine 5.5  (2.3) 5.7  (3.5) 9.4  (1.1) 9.3  (2.6)
2.Secondary Outcome
Title Diastolic Blood Pressure (DBP)
Hide Description Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
Drug-Change in DBP pre-to-post slot machine 20.2  (24.5) 22  (23.6) 15.1  (18.6) 23.6  (23.8)
Placebo-Change in DBP pre-to-post slot machine 22.5  (24.8) 21.6  (29.3) 19.1  (24.8) 19  (23.4)
Drug-Change in DBP pre-amphetamine to peak amph 27.2  (24.4) 32.1  (25.1) 28.5  (30) 32.7  (30)
Placebo-Change in DBP pre-amphetamine to peak amp 33.6  (29.8) 35.2  (28) 26.6  (24.5) 36.3  (28.3)
3.Secondary Outcome
Title Cognitive Task Performance
Hide Description 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)
Time Frame At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of neutral categorized words
post-slots-GAM words under drug 91.6  (7.9) 94.0  (6.0) 94.8  (6.1) 91.0  (7.9)
post-slots-ALC words under drug 95.5  (8.4) 98.1  (7.6) 96.5  (6.6) 93.1  (8.9)
post-slots POS words under drug 91.3  (8.7) 95.3  (7.6) 93.7  (8.3) 88.3  (8.4)
post-slots NEG words under drug 89.1  (9.5) 96.5  (7.3) 89.6  (7.6) 87.9  (10.2)
post-slots GAM words under placebo 91.6  (8.1) 95.0  (5.3) 97.2  (7.2) 92.1  (5.3)
post-slots ALC words under placebo 94.8  (6.1) 99.0  (7.2) 97.0  (6.5) 93.3  (4.7)
post-slots POS words under placebo 92.7  (8.1) 94.9  (5.8) 93.7  (6.1) 86.8  (10.3)
post-slots NEG words under placebo 93.0  (10.4) 97.2  (13.4) 92.3  (4.8) 84.7  (6.7)
peak AMPH GAM words under drug 96.7  (3.4) 95.8  (4.5) 98.1  (4.5) 97.0  (5.9)
peak AMPH ALC words under drug 101.2  (3.6) 99.5  (4.6) 99.1  (3.9) 100.3  (5.4)
peak AMPH POS words under drug 98.2  (3.3) 98.7  (4.6) 97.2  (4.7) 96.3  (4.7)
peak AMPH NEG words under drug 99.5  (5.1) 99.4  (4.8) 96.8  (3.6) 98.7  (5.2)
peak AMPH GAM words under placebo 95.0  (4.9) 97.9  (5.8) 96.8  (2.9) 96.9  (5.3)
peak AMPH ALC words under placebo 99.9  (6.2) 99.9  (5.3) 100.2  (4.7) 97.5  (6.5)
peak AMPH POS words under placebo 98.4  (4.7) 97.7  (5.5) 97.8  (4.0) 95.1  (3.3)
peak AMPH NEG words under placebo 99.0  (6.5) 100.0  (3.4) 98.1  (5.7) 96.7  (4.4)
4.Secondary Outcome
Title Betting Behaviour in Laboratory-based Slot Machine Game
Hide Description Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)
Time Frame 1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: credits/spin on slot machine
Mean bet under drug 12.8  (7.2) 16.0  (10.4) 11.6  (7.8) 14.4  (10.0)
Mean bet under placebo 10.4  (9.3) 16.1  (12.4) 9.5  (10.8) 12.2  (9.5)
5.Secondary Outcome
Title Speed of Play on Slot Machine Game
Hide Description Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.
Time Frame 15-minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 control subjects were enrolled in this arm.
A total of 15 control subjects were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: individual spins/15-minutes
Spins/15-minutes under Drug 76.9  (35.4) 78.5  (34.5) 66.4  (27.9) 71.8  (30.5)
Spins/15-minutes under Placebo 88.6  (32.9) 68.4  (47.3) 72.2  (40.5) 66.7  (31.6)
6.Secondary Outcome
Title Winnings on Slot Machine Upon Completion of Game
Hide Description Credits
Time Frame 15-minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description:
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 pathological gamblers were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
A total of 15 controls were enrolled in this arm.
Overall Number of Participants Analyzed 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: credits
Winnings (Final Credit Tally) under drug 239  (305.1) 277.8  (300.2) 449.1  (669.6) 544.3  (820)
Winnings (Final Credit Tally) under Placebo 562.4  (658) 140.8  (325.7) 339.2  (427.4) 215  (214.8)
Time Frame Same day as drug administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Haloperidol - Pathological Gamblers Fluphenazine - Pathological Gamblers Haloperidol - Controls Fluphenazine - Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      2/15 (13.33%)      0/15 (0.00%)    
Nervous system disorders         
Akathisia * [1]  0/15 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Mild restlessness which is an expected side effect of haloperidol
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Daniela Lobo, Qualified Investigator for Study, Clinician-Scientist
Organization: Centre for Addiction and Mental Health
Phone: 416-535-8501 ext 36568
Responsible Party: Daniela Lobo, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02203786     History of Changes
Other Study ID Numbers: 232-2009
First Submitted: July 23, 2014
First Posted: July 30, 2014
Results First Submitted: January 20, 2016
Results First Posted: April 25, 2016
Last Update Posted: April 25, 2016