Trial Outcomes & Findings for Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence (NCT NCT01486810)
NCT ID: NCT01486810
Last Updated: 2019-04-24
Results Overview
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
during 1 week of study participation
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Lisdexamfetamine and Medication Management
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
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|---|---|
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Overall Study
STARTED
|
17
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|
Overall Study
COMPLETED
|
9
|
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Overall Study
NOT COMPLETED
|
8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Lisdexamfetamine and Medication Management
n=17 Participants
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
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|---|---|
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Age, Continuous
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43.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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10 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during 1 week of study participationPopulation: Although 17 participants were enrolled, one participant was lost to follow-up without any post-enrollment study data, therefore 16 participants were analyzed.
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Outcome measures
| Measure |
Lisdexamfetamine and Medication Management
n=16 Participants
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
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|---|---|
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Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
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12 Participants
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PRIMARY outcome
Timeframe: during 8 weeks of trial or length of participationPopulation: data available for 16 participants.
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Outcome measures
| Measure |
Lisdexamfetamine and Medication Management
n=16 Participants
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
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|---|---|
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Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
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118.1 mgs/day
Standard Deviation 40.4
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Adverse Events
Lisdexamfetamine and Medication Management
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lisdexamfetamine and Medication Management
n=16 participants at risk
Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Lisdexamfetamine: Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication management: All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
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|---|---|
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Gastrointestinal disorders
abdominal pain
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6.2%
1/16 • Number of events 1
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General disorders
appetite change
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37.5%
6/16 • Number of events 6
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Gastrointestinal disorders
constipation
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6.2%
1/16 • Number of events 1
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Cardiac disorders
increased heart rate
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12.5%
2/16 • Number of events 2
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Gastrointestinal disorders
diarrhea
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12.5%
2/16 • Number of events 2
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General disorders
dry mouth
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12.5%
2/16 • Number of events 2
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General disorders
headache
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6.2%
1/16 • Number of events 1
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Cardiac disorders
increased blood pressure
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6.2%
1/16 • Number of events 1
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General disorders
insomnia
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18.8%
3/16 • Number of events 3
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General disorders
jittery
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31.2%
5/16 • Number of events 5
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Gastrointestinal disorders
nausea
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6.2%
1/16 • Number of events 1
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Gastrointestinal disorders
vomiting
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6.2%
1/16 • Number of events 1
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General disorders
fatigue
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6.2%
1/16 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place