Cocaine Use Disorder
Conditions
Brief summary
This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
Interventions
DRUGPhendimetrazine
Phendimetrazine will be administered in divided doses twice daily.
DRUGCocaine
Intranasal cocaine will be administered during experimental sessions.
DRUGPlacebo
Placebo capsules will contain only cornstarch.
Sponsors
National Institute on Drug Abuse (NIDA)
William Stoops
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Recent cocaine use
Exclusion criteria
* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant * Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion * History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation * Females not currently using effective birth control * Contraindications to cocaine or phendimetrazine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | After at least seven days of maintenance placebo or target phendimetrazine dose | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance. |
Countries
United States
Participant flow
Pre-assignment details
Thirty subjects were enrolled, but one was removed from the study due to an adverse event, leading to 29 completers.
Participants by arm
| Arm | Count |
|---|---|
| Study Completers Baseline demographics for study completers | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Study Completers |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
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 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.
Time frame: After at least seven days of maintenance placebo or target phendimetrazine dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 0 mg Cocaine | .34 Cocaine Choices | Standard Error 0.34 |
| Placebo | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 20 mg Cocaine | 4.31 Cocaine Choices | Standard Error 0.81 |
| Placebo | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 40 mg Cocaine | 4.69 Cocaine Choices | Standard Error 0.89 |
| Placebo | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 80 mg Cocaine | 5.90 Cocaine Choices | Standard Error 0.8 |
| Phendimetrazine | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 80 mg Cocaine | 5.03 Cocaine Choices | Standard Error 0.87 |
| Phendimetrazine | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 0 mg Cocaine | .24 Cocaine Choices | Standard Error 0.15 |
| Phendimetrazine | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 40 mg Cocaine | 3.83 Cocaine Choices | Standard Error 0.85 |
| Phendimetrazine | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 20 mg Cocaine | 3.9 Cocaine Choices | Standard Error 0.85 |