Trial Outcomes & Findings for Behavioral Effects of Drugs (Inpatient): 38 (NCT NCT03954938)

Last Updated: 2024-05-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

5 participants

Primary outcome timeframe

One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

Results posted on

2024-05-23

Participant Flow

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).

Participant milestones

Participant milestones
Measure	BED IN 38 Within subjects study assessing three craving manipulations and three cocaine doses.
Overall Study STARTED	5
Overall Study Positive-80 mg Cocaine	5
Overall Study Look-80 mg Cocaine	5
Overall Study Positive-40 mg Cocaine	4
Overall Study Look-0 mg Cocaine	4
Overall Study Positive-0 mg Cocaine	3
Overall Study Look-40 mg Cocaine	3
Overall Study Negative-0 mg Cocaine	3
Overall Study Negative-40 mg Cocaine	3
Overall Study Negative-80 mg Cocaine	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BED IN 38 Within subjects study assessing three craving manipulations and three cocaine doses.
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1

Baseline Characteristics

Behavioral Effects of Drugs (Inpatient): 38

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Completing Subjects n=2 Participants Subjects who completed the full study (i.e., completed all craving induction and cocaine dose conditions)
Age, Continuous	51.5 years STANDARD_DEVIATION 3.54 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Neutral-Look-0 mg Cocaine n=2 Participants 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. Placebo: The reinforcing effects of placebo were determined based on the craving manipulation condition.	Positive-0 mg Cocaine n=2 Participants 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.	Negative-0 mg Cocaine n=2 Participants 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.	Neutral-Look-40 mg Cocaine n=2 Participants 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.	Positive-40 mg Cocaine n=2 Participants 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	Negative-40 mg Cocaine n=2 Participants 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	Neutral-Look-80 mg Cocaine n=2 Participants 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.	Positive-80 mg Cocaine n=2 Participants 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	Negative-80 mg Cocaine n=2 Participants 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
Number of Times Cocaine Was Selected	0 Times Cocaine Selected Standard Error 0	0 Times Cocaine Selected Standard Error 0	0 Times Cocaine Selected Standard Error 0	1.5 Times Cocaine Selected Standard Error 1.5	1 Times Cocaine Selected Standard Error 1	1.5 Times Cocaine Selected Standard Error 0.5	1 Times Cocaine Selected Standard Error 1	2 Times Cocaine Selected Standard Error 2	2 Times Cocaine Selected Standard Error 0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Neutral-Look-0 mg Cocaine n=2 Participants 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. Placebo: The reinforcing effects of placebo were determined based on the craving manipulation condition.	Positive-0 mg Cocaine n=2 Participants 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.	Negative-0 mg Cocaine n=2 Participants 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.	Neutral-Look-40 mg Cocaine n=2 Participants 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.	Positive-40 mg Cocaine n=2 Participants 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	Negative-40 mg Cocaine n=2 Participants 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	Neutral-Look-80 mg Cocaine n=2 Participants 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.	Positive-80 mg Cocaine n=2 Participants 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	Negative-80 mg Cocaine n=2 Participants 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
Cocaine Craving	1.5 units on a 10 point scale Standard Error .5	1 units on a 10 point scale Standard Error 1	.5 units on a 10 point scale Standard Error .5	1.5 units on a 10 point scale Standard Error .5	2.5 units on a 10 point scale Standard Error .5	1.5 units on a 10 point scale Standard Error .5	1 units on a 10 point scale Standard Error 0	3 units on a 10 point scale Standard Error 1	1.5 units on a 10 point scale Standard Error .5

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Positive-0 mg Cocaine n=3 participants at risk Participants instructed to respond positively to cocaine images and receive 0 mg cocaine	Positive-40 mg Cocaine n=4 participants at risk Participants instructed to respond positively to cocaine images and receive 40 mg cocaine	Positive-80 mg Cocaine n=5 participants at risk Participants instructed to respond positively to cocaine images and receive 80 mg cocaine	Look-0 mg Cocaine n=4 participants at risk Participants instructed to respond naturally to cocaine images and receive 0 mg cocaine	Look-40 mg Cocaine n=3 participants at risk Participants instructed to respond naturally to cocaine images and receive 40 mg cocaine	Look-80 mg Cocaine n=5 participants at risk Participants instructed to respond naturally to cocaine images and receive 80 mg cocaine	Negative-0 mg Cocaine n=3 participants at risk Participants instructed to respond negatively to cocaine images and receive 0 mg cocaine	Negative-40 mg Cocaine n=3 participants at risk Participants instructed to respond negatively to cocaine images and receive 40 mg cocaine	Negative-80 mg Cocaine n=2 participants at risk Participants instructed to respond negatively to cocaine images and receive 80 mg cocaine
Cardiac disorders Tachycardia	0.00% 0/3 • 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.	0.00% 0/4 • 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.	0.00% 0/5 • 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.	0.00% 0/4 • 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.	0.00% 0/3 • 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.	0.00% 0/5 • 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.	0.00% 0/3 • 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.	0.00% 0/3 • 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.	50.0% 1/2 • Number of events 1 • 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.

Additional Information

William W. Stoops

University of Kentucky

Phone: 8592575388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place