Cocaine Dependence
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 self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
Interventions
DRUGCocaine
Three active doses of cocaine will be made available for self-administration during experimental sessions.
DRUGPlacebo
Placebo cocaine will be made available for self-administration during experimental sessions.
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
* Cocaine dependence, 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 in which subjects made 9 choices between each available cocaine dose and one of three money alternatives. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Combination of One Drug Dose and One Money Value Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions.
Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions.
Placebo: Placebo cocaine is made available for self-administration during experimental sessions. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | AEs | 1 |
Baseline characteristics
| Characteristic | Randomized Combination of One Drug Dose and One Money Value |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 |
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 in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.
Time frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Value Alternative Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 2.75 cocaine choices | Standard Error 1.39 |
| Low Value Alternative Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 4.75 cocaine choices | Standard Error 1.24 |
| Low Value Alternative Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 7.38 cocaine choices | Standard Error 1.07 |
| Low Value Alternative Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 7.63 cocaine choices | Standard Error 1.12 |
| Medium Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 7.13 cocaine choices | Standard Error 1.13 |
| Medium Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 1.38 cocaine choices | Standard Error 0.53 |
| Medium Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 6.13 cocaine choices | Standard Error 1.47 |
| Medium Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 5.88 cocaine choices | Standard Error 1.17 |
| High Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg/70kg Cocaine | 6.38 cocaine choices | Standard Error 1.22 |
| High Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 3 mg/70 kg Cocaine | 4.00 cocaine choices | Standard Error 1.52 |
| High Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 10 mg/70 kg Cocaine | 6.38 cocaine choices | Standard Error 1.41 |
| High Value Reinforcer | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Cocaine | 1.38 cocaine choices | Standard Error 0.53 |