Adults 18 to 55, any sex, with Cocaine Use, Unspecified. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Times Cocaine Was SelectedPrimary· 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.
Group
Value
95% CI
Neutral-Look-0 mg Cocaine
0
± 0
Positive-0 mg Cocaine
0
± 0
Negative-0 mg Cocaine
0
± 0
Neutral-Look-40 mg Cocaine
1.5
± 1.5
Positive-40 mg Cocaine
1
± 1
Negative-40 mg Cocaine
1.5
± 0.5
Neutral-Look-80 mg Cocaine
1
± 1
Positive-80 mg Cocaine
2
± 2
Negative-80 mg Cocaine
2
± 0
Cocaine CravingSecondary· 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).
Group
Value
95% CI
Neutral-Look-0 mg Cocaine
1.5
± .5
Positive-0 mg Cocaine
1
± 1
Negative-0 mg Cocaine
.5
± .5
Neutral-Look-40 mg Cocaine
1.5
± .5
Positive-40 mg Cocaine
2.5
± .5
Negative-40 mg Cocaine
1.5
± .5
Neutral-Look-80 mg Cocaine
1
± 0
Positive-80 mg Cocaine
3
± 1
Negative-80 mg Cocaine
1.5
± .5
Adverse events — posted to ClinicalTrials.gov
Time frame: Two weeks of study participation.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by William Stoops
Last refreshed: 23 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03954938.