Trial Outcomes & Findings for Exenatide for Treating Cocaine Use Disorder (NCT NCT04941521)
NCT ID: NCT04941521
Last Updated: 2022-06-27
Results Overview
Treatment completion will be assessed by attendance at the end-of-treatment timepoint.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Week 6
Results posted on
2022-06-27
Participant Flow
Participant milestones
| Measure |
Exenatide and Drug Counseling
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exenatide for Treating Cocaine Use Disorder
Baseline characteristics by cohort
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Age, Continuous
|
50.33 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
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Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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3 participants
n=5 Participants
|
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Number of Years of Education
|
13.00 years
STANDARD_DEVIATION 3.60 • n=5 Participants
|
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Tobacco Dependency assessed by the Fagerstrom Test
Very Low Dependence
|
1 Participants
n=5 Participants
|
|
Tobacco Dependency assessed by the Fagerstrom Test
Low Dependence
|
0 Participants
n=5 Participants
|
|
Tobacco Dependency assessed by the Fagerstrom Test
Medium Dependence
|
1 Participants
n=5 Participants
|
|
Tobacco Dependency assessed by the Fagerstrom Test
High Dependence
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1 Participants
n=5 Participants
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|
Tobacco Dependency assessed by the Fagerstrom Test
Very High Dependence
|
0 Participants
n=5 Participants
|
|
number of days of use of cocaine in the past 30 days
|
18 days
STANDARD_DEVIATION 7 • n=5 Participants
|
|
number of days use of alcohol in the past 30 days
|
8 days
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
number of days use of marijuana in the past 30 days
|
8.33 days
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
number of years use of cocaine
|
17 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
number of years use of alcohol
|
9.33 years
STANDARD_DEVIATION 8.38 • n=5 Participants
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number of years use of Marijuana
|
3.33 years
STANDARD_DEVIATION 5.77 • n=5 Participants
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PRIMARY outcome
Timeframe: Week 6Treatment completion will be assessed by attendance at the end-of-treatment timepoint.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Feasibility as Assessed by Number of Participants Who Completed Treatment
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3 Participants
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PRIMARY outcome
Timeframe: From Week 1 to Week 6Adverse events (AEs) will be reported to study nurse during the course of treatment.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Drug Safety as Assessed by Total Number of Adverse Events Reported During Treatment
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7 adverse events
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PRIMARY outcome
Timeframe: From Week 1 to Week 6Urine drug screens were performed weekly. For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 300 ng/mL.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 1
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3 Participants
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|
Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 2
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3 Participants
|
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Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 3
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3 Participants
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Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 4
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2 Participants
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Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 5
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2 Participants
|
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Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results
week 6
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 0Enrollment will be assessed by the number of participants signing the informed consent.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
|
Feasibility as Assessed by Number of Participants Enrolled
|
3 Participants
|
SECONDARY outcome
Timeframe: From Week 1 to Week 6There were 6 study visits planned.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
|
|---|---|
|
Feasibility as Assessed by Number of Study Visits Attended
|
6 study visits
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From Week 1 to Week 6Retention will be assessed by the total number of completed study visits. A completed study visit is a visit in which the participant attended and received the study treatment.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Feasibility as Assessed by Retention as Indicated by Total Number of Completed Study Visits
|
6 completed study visits
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 6The Satisfaction Survey includes a 9-point likert scale that ranges from 1 to 9, with a higher score indicating greater acceptability.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey
treatment helpfulness
|
7.66 score on a scale
Standard Deviation 1.52
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Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey
treatment usefulness
|
6.00 score on a scale
Standard Deviation 3.00
|
|
Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey
desire to continue treatment
|
7.33 score on a scale
Standard Deviation 2.08
|
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Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey
likelihood of treatment recommendation
|
7.33 score on a scale
Standard Deviation 2.88
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SECONDARY outcome
Timeframe: From Week 1 to Week 6Timeline Followback (TLFB) administered once weekly.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 1
|
2 Participants
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 2
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2 Participants
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 3
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1 Participants
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 4
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2 Participants
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 5
|
1 Participants
|
|
Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week
week 6
|
2 Participants
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SECONDARY outcome
Timeframe: From Week 0 to Week 6The brief substance craving scale (BSCS) is a 16-item, self-report instrument that assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.)
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Clinical Effect of Exenatide as Indicated by Number of Participants Who Reported a Reduction in Craving by Week 6 as Indicated by Cocaine Craving on the Brief Substance Craving Scale
|
2 Participants
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SECONDARY outcome
Timeframe: From Week 0 to Week 6Drug demand will be measured by the computerized Cocaine Purchasing Task (CPT). The CPT asks participants how much cocaine they would purchase at the beginning of a hypothetical day as the cost of cocaine increases from $0 to $1,000. The CPT simulates changes in price and consumption of drug in order to assess demand curves associated with drug consumption. The CPT will assess both cocaine reward value as well as motivation to consume cocaine.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Had a Decrease in Drug Demand by Week 6
|
1 Participants
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SECONDARY outcome
Timeframe: Week 6The Beck Depression Inventory score ranges from 0 to 63, with a higher score indicating greater depressive symptoms. The scores from each timepoint will be plotted as a trend line.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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Clinical Effect of Exenatide as Assessed by Number of Participants Who Were Below the Clinical Range for Depression by Week 6 as Indicated by the Beck Depression Inventory
|
3 Participants
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SECONDARY outcome
Timeframe: From Week 0 to Week 6The Positive/Negative Affect Schedule is a 20-item questionnaire divided into 10 positive affect items and 10 negative affect items. The score for the positive affect items ranges from 10 to 50, with a higher score indicating higher levels of positive affect. The scores from each timepoint will be plotted as a trend line.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
|
|---|---|
|
Clinical Effect of Exenatide as Indicated by Number of Participants Who Had an Increase in Positive Affect Symptoms by Week 6 as Indicated on the Positive/Negative Affect Schedule
|
1 Participants
|
SECONDARY outcome
Timeframe: From Week 0 to Week 6The Positive/Negative Affect Schedule is a 20-item questionnaire divided into 10 positive affect items and 10 negative affect items. The score for the negative affect items ranges from 10 to 50, with a lower score indicating lower levels of negative affect. The scores from each timepoint will be plotted as a trend line.
Outcome measures
| Measure |
Exenatide and Drug Counseling
n=3 Participants
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
|
|---|---|
|
Clinical Effect of Exenatide as Indicated by Number of Participants Who Had a Decrease in Negative Affect Symptoms Indicated on the Positive/Negative Affect Schedule
|
1 Participants
|
Adverse Events
Exenatide and Drug Counseling
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide and Drug Counseling
n=3 participants at risk
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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General disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • 6 weeks
|
Other adverse events
| Measure |
Exenatide and Drug Counseling
n=3 participants at risk
Participants will receive once weekly exenatide injections and drug counseling sessions.
Exenatide 2 mg \[Bydureon\]: Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
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|---|---|
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General disorders
Nausea
|
33.3%
1/3 • 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • 6 weeks
|
|
General disorders
Headache
|
33.3%
1/3 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Injection Site Pruritus
|
66.7%
2/3 • 6 weeks
|
Additional Information
Joy M Schmitz, PhD
The University of Texas Health Science at Houston
Phone: 713-486-2867
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place