Trial Outcomes & Findings for Prazosin for ETOH or Cocaine Craving (NCT NCT00240227)

NCT ID: NCT00240227

Last Updated: 2018-08-31

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: During lab session
• Results posted on: 2018-08-31

Participant Flow

Participants were randomized to one of two sequences, either placebo first or prazosin first. However, the precise numbers of which sequence participants were randomized to are no longer available considering the time (7 years) since the study was completed.

Participant milestones

Measure	All Study Participants No active medication Prazosin flexible dose titration up to 12 mg per day. Prazosin: FDA approved medication for hypertension
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prazosin for ETOH or Cocaine Craving

Baseline characteristics by cohort

Measure	All Study Paricipants n=8 Participants No active medication Prazosin FDA approved medication for hypertension
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: During lab session

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During lab session

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During lab session

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During lab session

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: Study was terminated early. No final analyses completed.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prazosin

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	Placebo n=8 participants at risk Placebo no active medication placebo	Prazosin n=8 participants at risk Prazosin flexible dose titration up to 12 mg per day. Prazosin: FDA approved medication for hypertension
Nervous system disorders dizziness	0.00% 0/8	12.5% 1/8 • Number of events 1

Additional Information

Andrew J. Saxon, M.D.

VA Puget Sound Health Care System

Phone: 206-764-2782

Email: andrew.saxon@va.gov

Results disclosure agreements

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