Trial Outcomes & Findings for Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin (NCT NCT01178138)

NCT ID: NCT01178138

Last Updated: 2016-12-30

Results Overview

Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales. Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect). In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 0 hr time point after prazosin and 1 hr time point after methamphetamine
• Results posted on: 2016-12-30

Participant Flow

Participant milestones

Measure	Prazosin Effects on Methamphetamine Double blind, placebo controlled study of the effect of prazosin on methamphetamine The order of placebo vs. active medication will be randomized. oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo. General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine. Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri). Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)
Overall Study STARTED	24
Overall Study Completed 6 Sessions	1
Overall Study Completed 5 Sessions	1
Overall Study Completed 3 Sessions	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Prazosin Effects on Methamphetamine Double blind, placebo controlled study of the effect of prazosin on methamphetamine The order of placebo vs. active medication will be randomized. oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo. General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine. Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri). Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	7
Overall Study Physician Decision	8

Baseline Characteristics

Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin

Baseline characteristics by cohort

Measure	Prazosin Effects on Methamphetamine n=3 Participants The order of placebo vs. active medication will be randomized. oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo. General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine. Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri). * Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) * Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) * Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) * Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) * Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) * Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)
Age, Continuous	42.6 years STANDARD_DEVIATION 9.2 • n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Gender Female	3 Participants n=93 Participants
Gender Male	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: 0 hr time point after prazosin and 1 hr time point after methamphetamine

Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales.

Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect).

In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again.

Outcome measures

Measure	Prazosin Placebo and Methamphetamine Placebo n=3 Participants The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.	Prazosin 1 mg and Methamphetamine Placebo n=3 Participants	Prazosin 2 mg and Methamphetamine Placebo n=2 Participants	Prazosin 1 mg and Methamphetamine 20 mg n=2 Participants	Prazosin 2 mg and Methamphetamine 20 mg n=1 Participants	Prazosin Placebo and Methamphetamine 20 mg n=3 Participants
Self-report Effects of High. VAS baseline	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0
Self-report Effects of High. VAS after methamphetamine	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	10 units on a scale Standard Deviation 14.1	15 units on a scale Standard Deviation 0	16.7 units on a scale Standard Deviation 15.3

PRIMARY outcome

Timeframe: 0 hr time point after prazosin and 1 hr time point after methamphetamine

Heart effects of prazosin on methamphetamine;

In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again.

Outcome measures

Measure	Prazosin Placebo and Methamphetamine Placebo n=3 Participants The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.	Prazosin 1 mg and Methamphetamine Placebo n=3 Participants	Prazosin 2 mg and Methamphetamine Placebo n=2 Participants	Prazosin 1 mg and Methamphetamine 20 mg n=2 Participants	Prazosin 2 mg and Methamphetamine 20 mg n=1 Participants	Prazosin Placebo and Methamphetamine 20 mg n=3 Participants
Heart Effects of Prazosin on Methamphetamine Heart rate baseline	78.7 beats per minute Standard Deviation 12.5	74 beats per minute Standard Deviation 10.1	74 beats per minute Standard Deviation 0	75.5 beats per minute Standard Deviation 3.5	80 beats per minute Standard Deviation 0	80 beats per minute Standard Deviation 9.1
Heart Effects of Prazosin on Methamphetamine Heart rate methamphetamine	72.7 beats per minute Standard Deviation 14.1	83.3 beats per minute Standard Deviation 10.4	81 beats per minute Standard Deviation 9.9	81.5 beats per minute Standard Deviation 9.2	70 beats per minute Standard Deviation 0	82 beats per minute Standard Deviation 6.2

PRIMARY outcome

Timeframe: 0 hr time point after prazosin and 1 hr time point after methamphetamine

Blood pressure effects of prazosin on methamphetamine;

In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again.

Outcome measures

Measure	Prazosin Placebo and Methamphetamine Placebo n=3 Participants The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.	Prazosin 1 mg and Methamphetamine Placebo n=3 Participants	Prazosin 2 mg and Methamphetamine Placebo n=2 Participants	Prazosin 1 mg and Methamphetamine 20 mg n=2 Participants	Prazosin 2 mg and Methamphetamine 20 mg n=1 Participants	Prazosin Placebo and Methamphetamine 20 mg n=3 Participants
Blood Pressure Effects of Prazosin on Methamphetamine systolic blood pressure baseline	119.3 mmHg Standard Deviation 14.6	110.3 mmHg Standard Deviation 8.5	113.5 mmHg Standard Deviation 10.6	126.5 mmHg Standard Deviation 7.8	105 mmHg Standard Deviation 0	123 mmHg Standard Deviation 20.7
Blood Pressure Effects of Prazosin on Methamphetamine systolic blood pressure after methamphetamine	131.7 mmHg Standard Deviation 15.5	114.3 mmHg Standard Deviation 9.5	122 mmHg Standard Deviation 4.2	131 mmHg Standard Deviation 14.1	107 mmHg Standard Deviation 0	119.7 mmHg Standard Deviation 6.7

Adverse Events

Prazosin Effects on Methamphetamine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prazosin Effects on Methamphetamine n=3 participants at risk Randomized placebo controlled trial of prazosin effects on methamphetamine
Vascular disorders hypotension	33.3% 1/3 • Number of events 1 • 8 hr

Additional Information

W. Brooks Gentry, MD

University of Arkansas for Medical Sciences

Phone: 501 686 6119

Email: gentrywilliamb@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place