Trial Outcomes & Findings for Study of the Medication Prazosin for Alcohol Dependence (NCT NCT00762710)

Last Updated: 2020-06-04

Results Overview

At the baseline and final medication visits, the Form 90 (19) was used to assess alcohol and drug use for the preceding 90-day period

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-06-04

Participant Flow

Recruitment began in January 2008 and ended June 2014. Six hundred and one people responding to flyers and newspaper advertisements and contacted the study, 151 provided informed consent, and 19 women and 73 men (N = 92) were randomized. Both civilian and veteran participants were seen in an outpatient VA clinic.

Of the 151 consented into the study, 59 did not go onto be randomized because of the following: Declined after screen (N=11) (includes missing baseline/first medication appointment) Ineligible at screen (N=48) * PTSD (N=11) * Acute illness (N=7) * Drug dependence (N=4) * Drinking inclusion not met (N=20) * Other (N=6)

Participant milestones

Participant milestones
Measure	Prazosin Prazosin medication Prazosin medication: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Placebo Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg
Overall Study STARTED	48	44
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	21	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Medication Prazosin for Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prazosin n=48 Participants Prazosin medication Prazosin medication: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Placebo n=44 Participants Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=99 Participants	44 Participants n=107 Participants	92 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 9.8 • n=99 Participants	49.1 years STANDARD_DEVIATION 9.5 • n=107 Participants	48.1 years STANDARD_DEVIATION 9.7 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	8 Participants n=107 Participants	19 Participants n=206 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	36 Participants n=107 Participants	73 Participants n=206 Participants
Region of Enrollment United States	48 Participants n=99 Participants	44 Participants n=107 Participants	92 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Providing baseline and last week of medication information for all participants that completed the titration period (40 in each group).

At the baseline and final medication visits, the Form 90 (19) was used to assess alcohol and drug use for the preceding 90-day period

Outcome measures

Outcome measures
Measure	Prazosin n=40 Participants Prazosin medication Prazosin medication: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Placebo n=40 Participants Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg
Alcohol Consumption Baseline % Days Heavy Drinking	71.8 percentage of days heavy drinking Standard Deviation 29.1	66.5 percentage of days heavy drinking Standard Deviation 26.0
Alcohol Consumption Final medication week % Days Heavy Drinking	11.4 percentage of days heavy drinking Standard Deviation 22.8	22.6 percentage of days heavy drinking Standard Deviation 34.1

Adverse Events

Prazosin

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Prazosin n=48 participants at risk Prazosin medication Prazosin medication: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Placebo n=44 participants at risk Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg
Psychiatric disorders Death	0.00% 0/48 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.	2.3% 1/44 • Number of events 1 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.
Infections and infestations Medical hospitalization	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.	0.00% 0/44 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.
Gastrointestinal disorders medical hospitalization	0.00% 0/48 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.	2.3% 1/44 • Number of events 1 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.
Psychiatric disorders inpatient alcohol detoxification	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.	0.00% 0/44 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.

Other adverse events

Other adverse events
Measure	Prazosin n=48 participants at risk Prazosin medication Prazosin medication: Form: Prazosin will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg	Placebo n=44 participants at risk Placebo medication Placebo medication: Form: Placebo will be taken orally, in the form of pills. Dosing: 9 AM, 3 PM, 9 PM Days 1-2: 0 mg, 0 mg, 1 mg Days 3-4: 1 mg, 1 mg, 1 mg Days 5-7: 2 mg, 2 mg, 2 mg Day 8-10: 2 mg, 2 mg, 6 mg Day 11-14: 4 mg, 4 mg, 6 mg Day 15-84: 4 mg, 4 mg, 8 mg
General disorders Drowsiness	58.3% 28/48 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.	34.1% 15/44 • Participants were monitored for adverse events after they started taking medications and about one month after they discontinued the medications. Because a few participants withdrew from the study after the baseline, where medications were dispensed, adverse events were monitored from one week to 16 weeks, depending on the length of participants' participation in the study. Participants were queried at every study visit with regard to potential adverse events and underwent clinical safety checks (e.g., sitting and stand blood pressures) at each visit.

Additional Information

Dr. Tracy Simpson

VA Puget Sound

Phone: (206) 277-3337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place