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Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence (Vyvance)

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ClinicalTrials.gov Identifier: NCT01486810
Recruitment Status : Completed
First Posted : December 7, 2011
Results First Posted : July 11, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Drug: Lisdexamfetamine
Behavioral: medication management
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lisdexamfetamine and Medication Management
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 17
Completed 9
Not Completed 8
Arm/Group Title Lisdexamfetamine and Medication Management
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
43.8  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
2
  11.8%
Male
15
  88.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
3
  17.6%
Not Hispanic or Latino
14
  82.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
American Indian or Alaska Native
1
   5.9%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  58.8%
White
3
  17.6%
More than one race
3
  17.6%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
Hide Description Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Time Frame during 1 week of study participation
Hide Outcome Measure Data
Hide Analysis Population Description
Although 17 participants were enrolled, one participant was lost to follow-up without any post-enrollment study data, therefore 16 participants were analyzed.
Arm/Group Title Lisdexamfetamine and Medication Management
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
12
  75.0%
2.Primary Outcome
Title Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
Hide Description The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Time Frame during 8 weeks of trial or length of participation
Hide Outcome Measure Data
Hide Analysis Population Description
data available for 16 participants.
Arm/Group Title Lisdexamfetamine and Medication Management
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: mgs/day
118.1  (40.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lisdexamfetamine and Medication Management
Hide Arm/Group Description

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.

All-Cause Mortality
Lisdexamfetamine and Medication Management
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lisdexamfetamine and Medication Management
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lisdexamfetamine and Medication Management
Affected / at Risk (%) # Events
Total   13/16 (81.25%)    
Cardiac disorders   
increased heart rate   2/16 (12.50%)  2
increased blood pressure   1/16 (6.25%)  1
Gastrointestinal disorders   
abdominal pain   1/16 (6.25%)  1
constipation   1/16 (6.25%)  1
diarrhea   2/16 (12.50%)  2
nausea   1/16 (6.25%)  1
vomiting   1/16 (6.25%)  1
General disorders   
appetite change   6/16 (37.50%)  6
dry mouth   2/16 (12.50%)  2
headache   1/16 (6.25%)  1
insomnia   3/16 (18.75%)  3
jittery   5/16 (31.25%)  5
fatigue   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
As this was an open label trial, future studies should evaluate lisdexamfetamine for the treatment cocaine use disorder under double-blind conditions.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Mariani
Organization: New York Psychiatric Institute
Phone: 646-774-8181
EMail: John.mariani@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: John Mariani MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01486810     History of Changes
Other Study ID Numbers: #6154
P50DA009236-18 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2011
First Posted: December 7, 2011
Results First Submitted: June 8, 2018
Results First Posted: July 11, 2018
Last Update Posted: April 24, 2019