Active Cocaine Users
Conditions
Brief summary
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
Interventions
DRUGCocaine
DRUGSustained Release d-Amphetamine
Sponsors
Joshua A. Lile, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Recent cocaine use, otherwise healthy
Exclusion criteria
* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 9 choice trials per cocaine dose level with each trial separated by 30 minutes | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine Cocaine choice during Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine | 7 |
| 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine | 5 |
| 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine | 4 |
| Total | 16 |
Baseline characteristics
| Characteristic | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | Total | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 16 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic/Latino Black Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino Black Female | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino Black Male | 3 Participants | 1 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino White Female | 0 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino White Male | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 5 Participants | 4 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 1 / 18 | 0 / 18 | 0 / 17 | 1 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 17 | 0 / 17 |
Outcome results
Primary
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.
Time frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 30 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 4.69 cocaine choices | Standard Error 0.89 |
| 30 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 0.06 cocaine choices | Standard Error 0.06 |
| 30 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 0.88 cocaine choices | Standard Error 0.43 |
| 30 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 1.88 cocaine choices | Standard Error 0.5 |
| Placebo Treatment | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 0.94 cocaine choices | Standard Error 0.35 |
| Placebo Treatment | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 6.00 cocaine choices | Standard Error 0.99 |
| Placebo Treatment | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 5.13 cocaine choices | Standard Error 0.93 |
| Placebo Treatment | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 2.50 cocaine choices | Standard Error 0.89 |
| 60 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 5.19 cocaine choices | Standard Error 0.95 |
| 60 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 0.56 cocaine choices | Standard Error 0.26 |
| 60 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 1.50 cocaine choices | Standard Error 0.51 |
| 60 mg d-Amphetamine | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 0.75 cocaine choices | Standard Error 0.36 |