Cocaine Use, Unspecified
Conditions
Brief summary
The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for cocaine use disorder will complete an outpatient, crossover, placebo-controlled study consisting of 1 practice and 9 experimental sessions. In each experimental session, the reinforcing effects of intranasal cocaine will be determined under one of three regulation of craving conditions that simulate CBT decisional analysis (i.e., negative instruction, positive instruction or a neutral look condition). After sampling the dose of cocaine available in each session, subjects will complete the craving manipulation assigned to that session, they will then rate their craving and finally they will have the opportunity to earn the sampled dose in a progressive-ratio procedure. We hypothesize that focusing on the negative effects of cocaine use will decrease craving and reduce cocaine self-administration relative to the positive and look conditions, and that craving will be positively correlated with self-administration outcomes.
Interventions
BEHAVIORALCraving Manipulation
Craving will be manipulated based on instructions about cocaine associated images shown to subjects.
DRUGCocaine
The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.
DRUGPlacebo
The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.
Sponsors
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
* Current 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 use disorder 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Times Cocaine Was Selected | One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cocaine Craving | Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. | Cocaine craving was assessed using a 10 point craving questionnaire that asks subjects to rate how much they are craving cocaine at that moment. The minimum craving score is 0 (i.e., no craving), the maximum craving score is 10 (i.e., highest craving). |
Countries
United States
Participant flow
Pre-assignment details
This is a 3x3 fully factorial crossover study with 9 conditions tested in random order in each completing subject. The factors are cocaine dose (0, 40, 80 mg) and craving manipulation (positive \[anticipate positive aspects of consuming cocaine\], negative \[anticipate negative aspects of consuming cocaine\], neutral \[respond naturally\]). Each of these conditions was combined (e.g., 0 mg cocaine with positive craving manipulation).
Participants by arm
| Arm | Count |
|---|---|
| Completing Subjects Subjects who completed the full study (i.e., completed all craving induction and cocaine dose conditions) | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Completing Subjects |
|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 3.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 3 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 3 | 0 / 3 | 1 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 5 | 0 / 3 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Number of Times Cocaine Was Selected
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions.
Time frame: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
Population: Completing Subjects; Only data from completing subjects included due to within subjects design of the project.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neutral-Look-0 mg Cocaine | Number of Times Cocaine Was Selected | 0 Times Cocaine Selected | Standard Error 0 |
| Positive-0 mg Cocaine | Number of Times Cocaine Was Selected | 0 Times Cocaine Selected | Standard Error 0 |
| Negative-0 mg Cocaine | Number of Times Cocaine Was Selected | 0 Times Cocaine Selected | Standard Error 0 |
| Neutral-Look-40 mg Cocaine | Number of Times Cocaine Was Selected | 1.5 Times Cocaine Selected | Standard Error 1.5 |
| Positive-40 mg Cocaine | Number of Times Cocaine Was Selected | 1 Times Cocaine Selected | Standard Error 1 |
| Negative-40 mg Cocaine | Number of Times Cocaine Was Selected | 1.5 Times Cocaine Selected | Standard Error 0.5 |
| Neutral-Look-80 mg Cocaine | Number of Times Cocaine Was Selected | 1 Times Cocaine Selected | Standard Error 1 |
| Positive-80 mg Cocaine | Number of Times Cocaine Was Selected | 2 Times Cocaine Selected | Standard Error 2 |
| Negative-80 mg Cocaine | Number of Times Cocaine Was Selected | 2 Times Cocaine Selected | Standard Error 0 |
Secondary
Cocaine Craving
Cocaine craving was assessed using a 10 point craving questionnaire that asks subjects to rate how much they are craving cocaine at that moment. The minimum craving score is 0 (i.e., no craving), the maximum craving score is 10 (i.e., highest craving).
Time frame: Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.
Population: Completing Subjects; Only data from completing subjects analyzed due to within subjects design of the project.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neutral-Look-0 mg Cocaine | Cocaine Craving | 1.5 units on a 10 point scale | Standard Error 0.5 |
| Positive-0 mg Cocaine | Cocaine Craving | 1 units on a 10 point scale | Standard Error 1 |
| Negative-0 mg Cocaine | Cocaine Craving | .5 units on a 10 point scale | Standard Error 0.5 |
| Neutral-Look-40 mg Cocaine | Cocaine Craving | 1.5 units on a 10 point scale | Standard Error 0.5 |
| Positive-40 mg Cocaine | Cocaine Craving | 2.5 units on a 10 point scale | Standard Error 0.5 |
| Negative-40 mg Cocaine | Cocaine Craving | 1.5 units on a 10 point scale | Standard Error 0.5 |
| Neutral-Look-80 mg Cocaine | Cocaine Craving | 1 units on a 10 point scale | Standard Error 0 |
| Positive-80 mg Cocaine | Cocaine Craving | 3 units on a 10 point scale | Standard Error 1 |
| Negative-80 mg Cocaine | Cocaine Craving | 1.5 units on a 10 point scale | Standard Error 0.5 |