Trial Outcomes & Findings for Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence (NCT NCT02111798)

Last Updated: 2025-02-27

Results Overview

Comparison of the number of thrice-weekly urine tests submitted during weeks study 7-30 negative for cocaine for persons randomly assigned to receive placebo or bupropion XL during weeks 7-30; excused samples are omitted and missing samples are treated as positive.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

83 participants

Primary outcome timeframe

Weeks 7-30

Results posted on

2025-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo/Abstinence Initiation Twice daily capsules filled with placebo powder + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Abstinence Initiation Twice daily capsules filled with bupropion extended release, 150mg (300mg daily) + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Placebo/Relapse Prevention Twice daily capsules filled with placebo + participants who provided \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Relapse Prevention Twice daily capsules filled with bupropion extended release, 150mg (300mg daily) + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial
Overall Study STARTED	31	32	10	10
Overall Study COMPLETED	20	16	10	7
Overall Study NOT COMPLETED	11	16	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion-Enhanced Contingency Management (CM) for Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Abstinence Initiation n=31 Participants Twice daily capsules filled with placebo powder + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Abstinence Initiation n=32 Participants Twice daily capsules filled with bupropion 150mg + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Placebo/Relapse Prevention n=10 Participants Twice daily capsules filled with placebo powder + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Relapse Prevention n=10 Participants Twice daily capsules filled with bupropion 150mg + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Total n=83 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 4.9 • n=5 Participants	46.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	48.5 years STANDARD_DEVIATION 9.8 • n=5 Participants	41.3 years STANDARD_DEVIATION 11.8 • n=4 Participants	45.2 years STANDARD_DEVIATION 9.0 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	27 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	60 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	31 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	81 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 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	0 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	43 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	16 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (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	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 7-30

Population: Comparisons are conducted as a function of study medication as that is the only variable for which randomization occurred.

Outcome measures

Outcome measures
Measure	Placebo/Abstinence Initiation n=31 Participants Twice daily capsules filled with placebo powder + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Abstinence Initiation n=32 Participants Twice daily capsules filled with bupropion XL 150mg + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Placebo/Relapse Prevention n=10 Participants Twice daily capsules filled with placebo powder + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Relapse Prevention n=10 Participants Twice daily capsules filled with bupropion XL 150mg + participants who not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial
Number of Cocaine Negative Urines	70.6 Mean percent negative urines Standard Error .01	57.7 Mean percent negative urines Standard Error .01	4.2 Mean percent negative urines Standard Error .01	14.5 Mean percent negative urines Standard Error .01

SECONDARY outcome

Timeframe: Weeks 7-30

Comparison of the longest string of urine samples testing negative for cocaine that were submitted at thrice weekly visits between weeks 7-30 from persons who were randomly assigned to receive placebo or bupropion XL; samples that were excused are omitted otherwise missing samples are treated as positive.

Outcome measures

Outcome measures
Measure	Placebo/Abstinence Initiation n=31 Participants Twice daily capsules filled with placebo powder + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Abstinence Initiation n=32 Participants Twice daily capsules filled with bupropion XL 150mg + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Placebo/Relapse Prevention n=10 Participants Twice daily capsules filled with placebo powder + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Relapse Prevention n=10 Participants Twice daily capsules filled with bupropion XL 150mg + participants who not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial
Longest Consecutive Period of Negative Urine Samples	7.8 Mean consecutive negative urines Standard Error 2.0	11.25 Mean consecutive negative urines Standard Error 3.3	52.9 Mean consecutive negative urines Standard Error 7.0	33.3 Mean consecutive negative urines Standard Error 7.2

Adverse Events

Placebo/Abstinence Initiation

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Bupropion XL/Abstinence Initiation

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo/Relapse Prevention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Bupropion XL/Relapse Prevention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Kelly Dunn, Ph.D., MBA

Johns Hopkins University School of Medicine

Phone: 410-550-2254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo/Abstinence Initiation n=31 participants at risk Twice daily capsules filled with placebo powder + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Abstinence Initiation n=32 participants at risk Twice daily capsules filled with bupropion XL 150mg + participants who did not provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Placebo/Relapse Prevention n=10 participants at risk Twice daily capsules filled with placebo powder + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial	Bupropion XL/Relapse Prevention n=10 participants at risk Twice daily capsules filled with bupropion XL 150mg + participants who did provide \>/=3 consecutive negative urine samples during weeks 1-6 of the trial
Gastrointestinal disorders Stomach cramps	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Blood and lymphatic system disorders Chills	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Blood and lymphatic system disorders Headache	9.7% 3/31 • Number of events 3 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	9.4% 3/32 • Number of events 3 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Cardiac disorders Hypertension	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Gastrointestinal disorders Abdominal Cramps	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	10.0% 1/10 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Gastrointestinal disorders Abdominal Pain	6.5% 2/31 • Number of events 2 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/32 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	10.0% 1/10 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Gastrointestinal disorders Gastro Esophageal Reflux Disease (GERD)	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/32 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	10.0% 1/10 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Gastrointestinal disorders Vomiting	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	10.0% 1/10 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Musculoskeletal and connective tissue disorders Pain, Lower Extremity	6.5% 2/31 • Number of events 2 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/32 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Psychiatric disorders Depression	3.2% 1/31 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	15.6% 5/32 • Number of events 5 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Nervous system disorders Dizziness	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/32 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	10.0% 1/10 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Nervous system disorders Drowsiness	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Skin and subcutaneous tissue disorders Skin Rash	3.2% 1/31 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.
Ear and labyrinth disorders Tinnitus	0.00% 0/31 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	3.1% 1/32 • Number of events 1 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.	0.00% 0/10 • Adverse events represent all events rated as "possibly, probably, or definitely" related to study participation, that were reported by participants to study staff during thrice weekly visits over a 23 week period during study weeks 7 - 30.