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

• 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: Centre for Addiction and Mental Health
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Subjective Reinforcement Self-report Scales
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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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)
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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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
Description	Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.
Time Frame	15-minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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
Description	Credits
Time Frame	15-minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Haloperidol - Pathological Gamblers	Fluphenazine - Pathological Gamblers	Haloperidol - Controls	Fluphenazine - Controls
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)

Adverse Events

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
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	--/--		--/--		--/--		--/--
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: Daniela.Lobo@camh.ca

Publications:

APA (2000) Diagnostic and Statistical Manual of Mental Disorders. IV-TR ed. American Psychiatric Association: Washington, DC.

Enggasser JL, de Wit H. Haloperidol reduces stimulant and reinforcing effects of ethanol in social drinkers. Alcohol Clin Exp Res. 2001 Oct;25(10):1448-56.

Holley FO, Magliozzi JR, Stanski DR, Lombrozo L, Hollister LE. Haloperidol kinetics after oral and intravenous doses. Clin Pharmacol Ther. 1983 Apr;33(4):477-84.

Lesieur HR, Blume SB. The South Oaks Gambling Screen (SOGS): a new instrument for the identification of pathological gamblers. Am J Psychiatry. 1987 Sep;144(9):1184-8.

Midha KK, McKay G, Edom R, Korchinski ED, Hawes EM, Hall K. Kinetics of oral fluphenazine disposition in humans by GC-MS. Eur J Clin Pharmacol. 1983;25(5):709-11.

Wachtel SR, Ortengren A, de Wit H. The effects of acute haloperidol or risperidone on subjective responses to methamphetamine in healthy volunteers. Drug Alcohol Depend. 2002 Sep 1;68(1):23-33.

Wong YN, Wang L, Hartman L, Simcoe D, Chen Y, Laughton W, Eldon R, Markland C, Grebow P. Comparison of the single-dose pharmacokinetics and tolerability of modafinil and dextroamphetamine administered alone or in combination in healthy male volunteers. J Clin Pharmacol. 1998 Oct;38(10):971-8.

• Responsible Party: Daniela Lobo, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT02203786
• 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