Trial Outcomes & Findings for Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse (NCT NCT00585780)
NCT ID: NCT00585780
Last Updated: 2020-07-27
Results Overview
Percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12 where heavy drinking day (HDD) is defined as 5 or more for men and 4 or more for women in one sitting, measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
daily over 12 weeks
Results posted on
2020-07-27
Participant Flow
Participant milestones
| Measure |
High Alcohol Withdrawal on Prazosin
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
High Alcohol Withdrawal on PLA
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
|
Low Alcohol Withdrawal on Prazosin
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
Low Alcohol Withdrawal on PLA
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
34
|
22
|
|
Overall Study
COMPLETED
|
13
|
14
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
Baseline characteristics by cohort
| Measure |
High Alcohol Withdrawal on Prazosin
n=21 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
High Alcohol Withdrawal on PLA
n=23 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
|
Low Alcohol Withdrawal on Prazosin
n=34 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
Low Alcohol Withdrawal on PLA
n=22 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
40.65 years
STANDARD_DEVIATION 10.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: daily over 12 weeksPopulation: Mean percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12
Percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12 where heavy drinking day (HDD) is defined as 5 or more for men and 4 or more for women in one sitting, measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments
Outcome measures
| Measure |
High Alcohol Withdrawal (AW) on Prazosin
n=21 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
High Alcohol Withdrawal (AW) on PLA
n=23 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
|
Low Alcohol Withdrawal (AW) on Prazosin
n=34 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
Low Alcohol Withdrawal (AW) on PLA
n=22 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12
|
8.2 percentage of heavy drinking days
Standard Error 4.09
|
27.11 percentage of heavy drinking days
Standard Error 7.97
|
31.29 percentage of heavy drinking days
Standard Error 7.42
|
7.32 percentage of heavy drinking days
Standard Error 3.54
|
PRIMARY outcome
Timeframe: daily over 12 weeksPercent of any drinkings days over the full dose period from weeks 3 to 12, defined as any alcoholic drink consumed each day measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments
Outcome measures
| Measure |
High Alcohol Withdrawal (AW) on Prazosin
n=21 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
High Alcohol Withdrawal (AW) on PLA
n=23 Participants
High AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or above 3 randomized to matching Placebo tablets (tid) for 12 weeks.
|
Low Alcohol Withdrawal (AW) on Prazosin
n=34 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 3 randomized to Prazosin 16 mg/day (tid) for 12 weeks.
|
Low Alcohol Withdrawal (AW) on PLA
n=22 Participants
Low AW (Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) scores at or below 2 randomized to matching Placebo tablets (tid) for 12 weeks.
|
|---|---|---|---|---|
|
Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12
|
26.89 Mean percent of any drinking days
Standard Error 7.45
|
41.21 Mean percent of any drinking days
Standard Error 9.36
|
53.35 Mean percent of any drinking days
Standard Error 7.74
|
23.71 Mean percent of any drinking days
Standard Error 6.90
|
Adverse Events
High Alcohol Withdrawal on Prazosin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Alcohol Withdrawal on PLA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Alcohol Withdrawal on Prazosin
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Low Alcohol Withdrawal on PLA
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Alcohol Withdrawal on Prazosin
n=21 participants at risk
High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks.
Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
|
High Alcohol Withdrawal on PLA
n=23 participants at risk
High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.
Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
|
Low Alcohol Withdrawal on Prazosin
n=34 participants at risk
Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks in a double blind manner.
Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
|
Low Alcohol Withdrawal on PLA
n=22 participants at risk
Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment and randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.
Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
|
|---|---|---|---|---|
|
Psychiatric disorders
Alcohol intoxication
|
0.00%
0/21 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
0.00%
0/23 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
0.00%
0/22 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
|
Social circumstances
weakness and fainting
|
0.00%
0/21 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
0.00%
0/23 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
0.00%
0/34 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
4.5%
1/22 • Number of events 1 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
Other adverse events
| Measure |
High Alcohol Withdrawal on Prazosin
n=21 participants at risk
High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks.
Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
|
High Alcohol Withdrawal on PLA
n=23 participants at risk
High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.
Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
|
Low Alcohol Withdrawal on Prazosin
n=34 participants at risk
Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks in a double blind manner.
Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
|
Low Alcohol Withdrawal on PLA
n=22 participants at risk
Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment and randomized to Placebo tablets administered tid for 12 weeks in a double blind manner.
Placebo Tablet: Placebo tablets identical in appearance and dosing schedule as the active study medication was utilized
|
|---|---|---|---|---|
|
Cardiac disorders
Ligtheadedness/dizzy
|
4.8%
1/21 • Number of events 2 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
4.3%
1/23 • Number of events 1 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
5.9%
2/34 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
4.5%
1/22 • Number of events 1 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
|
Nervous system disorders
Pain
|
9.5%
2/21 • Number of events 6 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
4.3%
1/23 • Number of events 3 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
11.8%
4/34 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
9.1%
2/22 • Number of events 7 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
4.3%
1/23 • Number of events 3 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
5.9%
2/34 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
9.1%
2/22 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
|
Infections and infestations
Cold and Flu
|
4.8%
1/21 • Number of events 5 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
8.7%
2/23 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
8.8%
3/34 • Number of events 4 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
9.1%
2/22 • Number of events 2 • Adverse event data obtained weekly for 12 week treatment period using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) assessing expected and unexpected side effects and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place