Trial Outcomes & Findings for Targeting Anhedonia in Cocaine Use Disorder (NCT NCT02773212)
NCT ID: NCT02773212
Last Updated: 2024-08-09
Results Overview
Subjects will complete a urine drug screen each visit. Achievement of cocaine abstinence will be defined as two consecutive weeks of cocaine-negative urine samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
At end of active treatment (Treatment week 4)
Results posted on
2024-08-09
Participant Flow
Participants completed the baseline measures of anhedonia after consent but before assignment to group. Two participants were consented but not randomized - 1 due to high blood pressure at the baseline session, 1 lost to followup before completing the baseline session
Participant milestones
| Measure |
d-Amphetamine and Contingency Management
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
19
|
|
Overall Study
COMPLETED
|
6
|
9
|
16
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Anhedonia in Cocaine Use Disorder
Baseline characteristics by cohort
| Measure |
d-Amphetamine and Contingency Management
n=21 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
n=15 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
n=19 Participants
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.91 years
STANDARD_DEVIATION 7.17 • n=5 Participants
|
51.87 years
STANDARD_DEVIATION 6.40 • n=7 Participants
|
50.74 years
STANDARD_DEVIATION 6.11 • n=5 Participants
|
51.22 years
STANDARD_DEVIATION 6.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
19 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Years of Education
|
14.29 years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
13.20 years
STANDARD_DEVIATION 2.21 • n=7 Participants
|
12.42 years
STANDARD_DEVIATION 1.54 • n=5 Participants
|
13.34 years
STANDARD_DEVIATION 1.91 • n=4 Participants
|
|
Monthly Income in Dollars
|
1796.82 USD
STANDARD_DEVIATION 1467.82 • n=5 Participants
|
1858 USD
STANDARD_DEVIATION 2217.13 • n=7 Participants
|
1390.57 USD
STANDARD_DEVIATION 1350.00 • n=5 Participants
|
1673.18 USD
STANDARD_DEVIATION 1650.29 • n=4 Participants
|
|
Location of Enrollment
Chicago
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Location of Enrollment
Houston
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At end of active treatment (Treatment week 4)Subjects will complete a urine drug screen each visit. Achievement of cocaine abstinence will be defined as two consecutive weeks of cocaine-negative urine samples.
Outcome measures
| Measure |
d-Amphetamine and Contingency Management
n=21 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
n=15 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
n=19 Participants
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
|---|---|---|---|
|
Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy)
|
3 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At end of active treatment (Treatment week 4)Subjects will complete a urine drug screen each visit (3x weekly). The Treatment Effectiveness Score is defined as the total number of cocaine negative urines across the 4 weeks of treatment (possible total of 12).
Outcome measures
| Measure |
d-Amphetamine and Contingency Management
n=21 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
n=15 Participants
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
n=19 Participants
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
|---|---|---|---|
|
Cocaine Negative Urine Samples
|
1.76 count of urines (range 0 - 12)
Standard Deviation 4.00
|
3.33 count of urines (range 0 - 12)
Standard Deviation 4.25
|
5.00 count of urines (range 0 - 12)
Standard Deviation 4.88
|
Adverse Events
d-Amphetamine and Contingency Management
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
d-Amphetamine Alone
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo and Contingency Management
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
d-Amphetamine and Contingency Management
n=21 participants at risk
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
n=15 participants at risk
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
n=19 participants at risk
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
|---|---|---|---|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • Number of events 1 • 7 weeks
|
Other adverse events
| Measure |
d-Amphetamine and Contingency Management
n=21 participants at risk
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
|
d-Amphetamine Alone
n=15 participants at risk
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
d-amphetamine: Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
|
Placebo and Contingency Management
n=19 participants at risk
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
Contingency management: Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
Placebo (for d-amphetamine): 60 mg of riboflavin and cornstarch as needed.
|
|---|---|---|---|
|
Psychiatric disorders
Low Energy
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
15.8%
3/19 • 7 weeks
|
|
Psychiatric disorders
Feeling Down
|
4.8%
1/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
10.5%
2/19 • 7 weeks
|
|
Psychiatric disorders
Increased Energy
|
4.8%
1/21 • 7 weeks
|
20.0%
3/15 • 7 weeks
|
10.5%
2/19 • 7 weeks
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Psychiatric disorders
Problems Concentrating
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Psychiatric disorders
Irritable Mood
|
14.3%
3/21 • 7 weeks
|
13.3%
2/15 • 7 weeks
|
10.5%
2/19 • 7 weeks
|
|
Psychiatric disorders
Hyperactivity/Restlessness
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Nervous system disorders
Drowsy
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Nervous system disorders
Change in Sleep Patterns
|
9.5%
2/21 • 7 weeks
|
20.0%
3/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Nervous system disorders
Abnormal Dreams
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
General disorders
Headache
|
4.8%
1/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Eye disorders
Blurry Vision
|
0.00%
0/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint/Muscle Pain
|
4.8%
1/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
26.3%
5/19 • 7 weeks
|
|
Cardiac disorders
Heart Racing
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
General disorders
Chills
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
General disorders
Increased Sweating
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Nervous system disorders
Tingling Skin
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
General disorders
Dry Mouth
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Renal and urinary disorders
Change in Urination
|
4.8%
1/21 • 7 weeks
|
13.3%
2/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
General disorders
Change in Appetite
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Gastrointestinal disorders
Black Stools
|
0.00%
0/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
General disorders
Change in Weight
|
0.00%
0/21 • 7 weeks
|
6.7%
1/15 • 7 weeks
|
0.00%
0/19 • 7 weeks
|
|
Nervous system disorders
Numb Fingers or Toes
|
4.8%
1/21 • 7 weeks
|
0.00%
0/15 • 7 weeks
|
5.3%
1/19 • 7 weeks
|
|
Cardiac disorders
High Blood Pressure
|
28.6%
6/21 • 7 weeks
|
60.0%
9/15 • 7 weeks
|
73.7%
14/19 • 7 weeks
|
|
Cardiac disorders
High Heart Rate
|
9.5%
2/21 • 7 weeks
|
20.0%
3/15 • 7 weeks
|
15.8%
3/19 • 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place