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COVID-19
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral-Look | Sham Comparator | Subjects will be instructed to look at cocaine associated images and respond naturally. |
|
| Positive | Experimental | Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. |
|
| Negative | Active Comparator | Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Craving Manipulation | Behavioral | Craving will be manipulated based on instructions about cocaine associated images shown to subjects. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W Stoops, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky | 40507 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | BED IN 38 | Within subjects study assessing three craving manipulations and three cocaine doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Completing subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Completing Subjects | Subjects who completed the full study (i.e., completed all craving induction and cocaine dose conditions) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Completing Subjects; Only data from completing subjects included due to within subjects design of the project. | Posted | Mean | Standard Error | Times Cocaine Selected | One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. |
|
Two weeks of study participation
This is a crossover, factorial study in which all subjects were randomly assigned to experience 9 conditions in random order.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive-0 mg Cocaine | Participants instructed to respond positively to cocaine images and receive 0 mg cocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed; only completing subjects' data analyzed due to within subjects design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William W. Stoops | University of Kentucky | 8592575388 | william.stoops@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 | Apr 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Cocaine | Drug | The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition. |
|
| Placebo | Drug | The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Positive-0 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Placebo: The reinforcing effects of placebo were determined based on the craving manipulation condition. |
| OG002 | Negative-0 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Placebo: The reinforcing effects of placebo were determined based on the craving manipulation condition. Placebo: The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition. |
| OG003 | Neutral-Look-40 mg Cocaine | Subjects were instructed to look at cocaine associated images and respond naturally. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 40 mg cocaine were determined based on the craving manipulation condition. |
| OG004 | Positive-40 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 40 mg cocaine were determined based on the craving manipulation condition |
| OG005 | Negative-40 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 40 mg cocaine were determined based on the craving manipulation condition |
| OG006 | Neutral-Look-80 mg Cocaine | Subjects were instructed to look at cocaine associated images and respond naturally. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 80 mg cocaine were determined based on the craving manipulation condition. |
| OG007 | Positive-80 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 80 mg cocaine were determined based on the craving manipulation condition |
| OG008 | Negative-80 mg Cocaine | Subjects were instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown. Craving Manipulation: Craving was manipulated based on instructions about cocaine associated images shown to subjects. Cocaine: The reinforcing effects of 80 mg cocaine were determined based on the craving manipulation condition |
|
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| 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). | Completing Subjects; Only data from completing subjects analyzed due to within subjects design of the project. | Posted | Mean | Standard Error | units on a 10 point scale | Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation. |
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|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Positive-40 mg Cocaine | Participants instructed to respond positively to cocaine images and receive 40 mg cocaine | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Positive-80 mg Cocaine | Participants instructed to respond positively to cocaine images and receive 80 mg cocaine | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Look-0 mg Cocaine | Participants instructed to respond naturally to cocaine images and receive 0 mg cocaine | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Look-40 mg Cocaine | Participants instructed to respond naturally to cocaine images and receive 40 mg cocaine | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Look-80 mg Cocaine | Participants instructed to respond naturally to cocaine images and receive 80 mg cocaine | 0 | 5 | 0 | 5 | 0 | 5 |
| EG006 | Negative-0 mg Cocaine | Participants instructed to respond negatively to cocaine images and receive 0 mg cocaine | 0 | 3 | 0 | 3 | 0 | 3 |
| EG007 | Negative-40 mg Cocaine | Participants instructed to respond negatively to cocaine images and receive 40 mg cocaine | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | Negative-80 mg Cocaine | Participants instructed to respond negatively to cocaine images and receive 80 mg cocaine | 0 | 2 | 0 | 2 | 1 | 2 |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |