Cocaine Dependence
Conditions
Keywords
cocaine, treatment, lisdexamfetamine, dependence, addiction, crack
Brief summary
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.
Detailed description
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.
Interventions
DRUGlisdexamfetamine/Behavior Therapy
OTHERplacebo
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Eligible participants must: 1. Be treatment-seeking males or females between 18 and 65 years-of-age; 2. Understand the study procedures and provide written informed consent; 3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use; 4. Meet DSM-IV criteria for cocaine-dependence.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cocaine-positive Urine Results | 14 Weeks | At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Craving | 14 Weeks | On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine lisdexamfetamine 70mg/day
lisdexamfetamine
cognitive behavioral therapy | 22 |
| Placebo Placebo Comparator once per day
placebo
cognitive behavioral therapy | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Lisdexamfetamine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 5.9 | 46.1 years STANDARD_DEVIATION 7.9 | 46.4 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 26 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 4 Participants |
| Region of Enrollment United States | 22 participants | 43 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 1 / 22 | 1 / 21 |
Outcome results
Primary
Cocaine-positive Urine Results
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.
Time frame: 14 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine | Cocaine-positive Urine Results | 86.5 percentage of BE urine tests | Standard Deviation 0.5 |
| Placebo | Cocaine-positive Urine Results | 92.4 percentage of BE urine tests | Standard Deviation 0.5 |
Secondary
Drug Craving
On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much.
Time frame: 14 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine | Drug Craving | 17.5 units on a scale | Standard Error 3.3 |
| Placebo | Drug Craving | 28.7 units on a scale | Standard Error 3.21 |