Trial Outcomes & Findings for Evaluation of Doxazosin to Alter the Abuse of Oxycodone (NCT NCT03415581)
NCT ID: NCT03415581
Last Updated: 2021-04-12
Results Overview
Clinical laboratory task where the participant is asked to choose between drug and money. Shown as the mean percent of drug choices.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Averaged across the 8-week trial.
Results posted on
2021-04-12
Participant Flow
Participant milestones
| Measure |
Placebo Doxazosin, Then Active Doxazosin
Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
Active Doxazosin the Placebo Doxazosin
Maintenance on a daily dose of oral doxazosin (16 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Doxazosin to Alter the Abuse of Oxycodone
Baseline characteristics by cohort
| Measure |
Doxazosin (Placebo First)
n=7 Participants
Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks followed by active maintenance on doxazasin 16 mg (or the highest tolerated dose) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
Doxazosin (Active First)
n=6 Participants
Maintenance on a daily dose of oral doxazosin (up to 16 mg, or the highest tolerated dose) for 4 weeks, followed by maintenance on doxazosin 0 mg for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Averaged across the 8-week trial.Population: The number of participants analyzed for the measure represents 2 individuals who completed testing under both doxazosin and placebo maintenance conditions.
Clinical laboratory task where the participant is asked to choose between drug and money. Shown as the mean percent of drug choices.
Outcome measures
| Measure |
Placebo
n=2 Participants
Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
Doxazosin
n=2 Participants
Maintenance on a daily dose of oral doxazosin (16 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
|---|---|---|
|
Opioid Self-administration
Oxycodone 50 mg
|
45 Mean percentage of Drug Choices
Standard Deviation .26
|
46 Mean percentage of Drug Choices
Standard Deviation .03
|
|
Opioid Self-administration
Oxycodone 0 mg
|
33 Mean percentage of Drug Choices
Standard Deviation .92
|
38 Mean percentage of Drug Choices
Standard Deviation .57
|
|
Opioid Self-administration
Oxycodone 12.5 mg
|
40 Mean percentage of Drug Choices
Standard Deviation .44
|
47 Mean percentage of Drug Choices
Standard Deviation .16
|
|
Opioid Self-administration
Oxycodone 100 mg
|
46 Mean percentage of Drug Choices
Standard Deviation .03
|
44 Mean percentage of Drug Choices
Standard Deviation .21
|
|
Opioid Self-administration
Oxycodone 25 mg
|
43 Mean percentage of Drug Choices
Standard Deviation .07
|
44 Mean percentage of Drug Choices
Standard Deviation .04
|
SECONDARY outcome
Timeframe: Averaged across the 8-week trial.Population: The number of participants analyzed for the measure represents 2 individuals who completed testing under both doxazosin and placebo maintenance conditions.
Self-reported craving for opioid drugs. Participants are asked to indicate the extent to which they agree with the phrase "I want opioids" on a scale of 0 (Not-at-All) to 100 (Completely).
Outcome measures
| Measure |
Placebo
n=2 Participants
Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
Doxazosin
n=2 Participants
Maintenance on a daily dose of oral doxazosin (16 mg) for 4 weeks. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Intranasal Oxycodone: Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
Cue Session: During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
|
|---|---|---|
|
Opioid Craving
Oxycodone 50 mg
|
22.5 units on a scale (0-100)
Standard Deviation 12.6
|
27.3 units on a scale (0-100)
Standard Deviation 13.7
|
|
Opioid Craving
Oxycodone 0 mg
|
33.6 units on a scale (0-100)
Standard Deviation 14.1
|
45.3 units on a scale (0-100)
Standard Deviation 15.1
|
|
Opioid Craving
Oxycodone 12.5 mg
|
43.3 units on a scale (0-100)
Standard Deviation 14.9
|
50.6 units on a scale (0-100)
Standard Deviation 15.6
|
|
Opioid Craving
Oxycodone 25 mg
|
30.5 units on a scale (0-100)
Standard Deviation 13.3
|
34.9 units on a scale (0-100)
Standard Deviation 13.7
|
|
Opioid Craving
Oxycodone 100 mg
|
24.5 units on a scale (0-100)
Standard Deviation 11.4
|
26.1 units on a scale (0-100)
Standard Deviation 12.3
|
Adverse Events
Placebo Maintenance
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Doxazosin Maintenance
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Maintenance
n=13 participants at risk
Maintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks.
|
Doxazosin Maintenance
n=13 participants at risk
Maintenance on a daily dose of oral doxazosin (16 mg, or the highest tolerated dose) for 4-weeks.
|
|---|---|---|
|
Cardiac disorders
Orthostasis
|
15.4%
2/13 • Number of events 8 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
38.5%
5/13 • Number of events 13 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
|
Cardiac disorders
Bradychardia
|
0.00%
0/13 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
|
General disorders
Chest Pain
|
0.00%
0/13 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
7.7%
1/13 • Number of events 1 • AEs and SAEs were assessed throughout the 8-week study period. Data are presented as a function of the 4-week period under which participants received placebo doxazosin, and the 4-week period during which they received active doxazosin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place