Trial Outcomes & Findings for Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving (NCT NCT01822587)
NCT ID: NCT01822587
Last Updated: 2019-12-26
Results Overview
Timeline of cocaine use throughout the duration of the study (in dollar amounts)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
Evaluated at Weeks 1, 3 and 6
Results posted on
2019-12-26
Participant Flow
Participant milestones
| Measure |
Placebo
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
62
|
|
Overall Study
COMPLETED
|
43
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
12
|
|
Overall Study
Physician Decision
|
9
|
6
|
6
|
Baseline Characteristics
Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
n=5 Participants
|
43.8 years
n=7 Participants
|
42.3 years
n=5 Participants
|
43.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed/Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
60 participants
n=7 Participants
|
62 participants
n=5 Participants
|
181 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Evaluated at Weeks 1, 3 and 6Timeline of cocaine use throughout the duration of the study (in dollar amounts)
Outcome measures
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Cocaine Use
Week 1
|
58.9 Dollar amounts of cocaine use
Standard Error 31.95
|
71.57 Dollar amounts of cocaine use
Standard Error 31.63
|
69.63 Dollar amounts of cocaine use
Standard Error 30.74
|
|
Cocaine Use
Week 3
|
121.25 Dollar amounts of cocaine use
Standard Error 32.67
|
177.67 Dollar amounts of cocaine use
Standard Error 32.34
|
135.81 Dollar amounts of cocaine use
Standard Error 31.93
|
|
Cocaine Use
Week 6
|
186.57 Dollar amounts of cocaine use
Standard Error 33.21
|
198.9 Dollar amounts of cocaine use
Standard Error 32.85
|
242.79 Dollar amounts of cocaine use
Standard Error 32.47
|
PRIMARY outcome
Timeframe: Single-Item Craving Scores are collected at all Retrieval Extinction Sessions (medication days), as well as all Phase Two Test Sessions (weeks 1,3 and 6).The participant is asked, "What is the level of craving you are experiencing on a scale or 0 to 100, with 0 representing no craving and 100 extreme craving"?
Outcome measures
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Change in Craving Score
Day 2
|
25.6 score on a scale
Standard Error 3.0
|
31.4 score on a scale
Standard Error 2.9
|
26.9 score on a scale
Standard Error 2.9
|
|
Change in Craving Score
Week 1
|
27.5 score on a scale
Standard Error 2.8
|
28.0 score on a scale
Standard Error 2.8
|
24.7 score on a scale
Standard Error 2.7
|
|
Change in Craving Score
Week 3
|
24.6 score on a scale
Standard Error 2.9
|
29.0 score on a scale
Standard Error 2.9
|
20.0 score on a scale
Standard Error 2.9
|
|
Change in Craving Score
Week 6
|
22.6 score on a scale
Standard Error 2.8
|
22.4 score on a scale
Standard Error 2.7
|
17.5 score on a scale
Standard Error 2.8
|
PRIMARY outcome
Timeframe: Week 1, Week 3, and Week 6How many days the participants used cocaine versus how many days of abstinence they were able to achieve.
Outcome measures
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Days of Abstinence
Week 1
|
20 Days
|
19 Days
|
17 Days
|
|
Days of Abstinence
Week 3
|
15 Days
|
14 Days
|
13 Days
|
|
Days of Abstinence
Week 6
|
15 Days
|
9 Days
|
7 Days
|
PRIMARY outcome
Timeframe: Day 2, Week 1, Week 3, and Week 6Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving).
Outcome measures
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Average Peak Craving Score
Day 2
|
16.1 score on a scale
Standard Error 3.5
|
23.3 score on a scale
Standard Error 3.4
|
18.1 score on a scale
Standard Error 3.3
|
|
Average Peak Craving Score
Week 1
|
15.2 score on a scale
Standard Error 3.5
|
19.6 score on a scale
Standard Error 3.5
|
17.1 score on a scale
Standard Error 3.5
|
|
Average Peak Craving Score
Week 3
|
13.1 score on a scale
Standard Error 3.6
|
19.7 score on a scale
Standard Error 3.6
|
10.1 score on a scale
Standard Error 3.5
|
|
Average Peak Craving Score
Week 6
|
10.2 score on a scale
Standard Error 3.6
|
12.1 score on a scale
Standard Error 3.6
|
5.5 score on a scale
Standard Error 3.7
|
PRIMARY outcome
Timeframe: Week 1, Week 3, Week 6Mean Days of Cocaine Use
Outcome measures
| Measure |
Placebo
n=59 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 Participants
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Use Days
Week 1
|
1.66 Days
Standard Error 0.54
|
1.61 Days
Standard Error 0.53
|
1.76 Days
Standard Error 0.52
|
|
Use Days
Week 3
|
3.33 Days
Standard Error 0.55
|
3.15 Days
Standard Error 0.54
|
3.51 Days
Standard Error 0.54
|
|
Use Days
Week 6
|
4.9 Days
Standard Error 0.56
|
4.49 Days
Standard Error 0.55
|
6.06 Days
Standard Error 0.55
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propranolol 40mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Propranolol, 80mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Administered once orally following cue exposure on each of the first two days of testing.
Placebo
|
Propranolol 40mg
n=60 participants at risk
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 40 mg
|
Propranolol, 80mg
n=62 participants at risk
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|---|---|---|---|
|
Psychiatric disorders
Participant Hospitalization
|
0.00%
0/59 • Adverse events will be monitored throughout the study (six weeks) and all events will be followed to resolution or stabilization.
A serious adverse event is one that meets any of the following criteria: 1. Fatal or life threatening 2. Requires or prolongs inpatient hospitalization 3. Results in persistent or significant disability/incapacity 4. Congenital anomaly 5. Medical event that may jeopardize the participant or require intervention to mitigate serious outcome 6. Cancer 7. Overdose
|
100.0%
1/1 • Number of events 1 • Adverse events will be monitored throughout the study (six weeks) and all events will be followed to resolution or stabilization.
A serious adverse event is one that meets any of the following criteria: 1. Fatal or life threatening 2. Requires or prolongs inpatient hospitalization 3. Results in persistent or significant disability/incapacity 4. Congenital anomaly 5. Medical event that may jeopardize the participant or require intervention to mitigate serious outcome 6. Cancer 7. Overdose
|
0.00%
0/62 • Adverse events will be monitored throughout the study (six weeks) and all events will be followed to resolution or stabilization.
A serious adverse event is one that meets any of the following criteria: 1. Fatal or life threatening 2. Requires or prolongs inpatient hospitalization 3. Results in persistent or significant disability/incapacity 4. Congenital anomaly 5. Medical event that may jeopardize the participant or require intervention to mitigate serious outcome 6. Cancer 7. Overdose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place