Trial · NCT02383043
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
NCT02383043, Early phase 1, Completed, Joshua A. Lile, Ph.D.; results first posted 2019-04-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer. Trials, record NCT02383043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02383043
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
- NCT number
- NCT02383043
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Conditions
- Active Cocaine Users
- Interventions
- Cocaine, Sustained Release d-Amphetamine
- First posted
- 2015-03-09
- Last updated
- 2019-04-11
- Results first posted
- 2019-04-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 9 choice trials per cocaine dose level with each trial separated by 30 minutes | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 9 choice trials per cocaine dose level with each trial separated by 30 minutes | cocaine choices | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg d-Amphetamine | Placebo Cocaine | 0.06 | Standard Error 0.06 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Treatment | Placebo Cocaine | 0.94 | Standard Error 0.35 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 60 mg d-Amphetamine | Placebo Cocaine | 0.75 | Standard Error 0.36 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg d-Amphetamine | 3 mg/70 kg Cocaine | 0.88 | Standard Error 0.43 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Treatment | 3 mg/70 kg Cocaine | 2.50 | Standard Error 0.89 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 60 mg d-Amphetamine | 3 mg/70 kg Cocaine | 0.56 | Standard Error 0.26 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg d-Amphetamine | 10 mg/70 kg Cocaine | 1.88 | Standard Error 0.50 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | Placebo Treatment | 10 mg/70 kg Cocaine | 5.13 | Standard Error 0.93 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 60 mg d-Amphetamine | 10 mg/70 kg Cocaine | 1.50 | Standard Error 0.51 | cocaine choices |
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | 30 mg d-Amphetamine | 30 mg/70kg Cocaine | 4.69 | Standard Error 0.89 | cocaine choices |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine | 9 | |
| Overall Study | STARTED | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine | 5 | |
| Overall Study | STARTED | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | 4 | |
| Overall Study | COMPLETED | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine | 7 | |
| Overall Study | COMPLETED | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine | 5 | |
| Overall Study | COMPLETED | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | 4 | |
| Overall Study | NOT COMPLETED | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine | 2 | |
| Overall Study | NOT COMPLETED | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine | 0 | |
| Overall Study | NOT COMPLETED | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest pain | Musculoskeletal and connective tissue disorders | Medical Safety Session | 0 | 18 | 0 |
| other | Chest pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 18 | 0 |
| other | Chest pain | Musculoskeletal and connective tissue disorders | 30 mg d-Amphetamine | 0 | 17 | 0 |
| other | Chest pain | Musculoskeletal and connective tissue disorders | 60 mg d-Amphetamine | 1 | 17 | 1 |
| other | Nausea and vomiting | Gastrointestinal disorders | Medical Safety Session | 1 | 18 | 1 |
| other | Nausea and vomiting | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
| other | Nausea and vomiting | Gastrointestinal disorders | 30 mg d-Amphetamine | 0 | 17 | 0 |
| other | Nausea and vomiting | Gastrointestinal disorders | 60 mg d-Amphetamine | 0 | 17 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medical Safety Session | 0 | 18 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | 30 mg d-Amphetamine | 0 | 17 |
| Total, all-cause mortality | 60 mg d-Amphetamine | 0 | 17 |
| Total, other adverse events | Medical Safety Session | 1 | 18 |
| Total, other adverse events | Placebo | 0 | 18 |
| Total, other adverse events | 30 mg d-Amphetamine | 0 | 17 |
| Total, other adverse events | 60 mg d-Amphetamine | 1 | 17 |
| Total, serious adverse events | Medical Safety Session | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA033364 | Medications Development for Cocaine: A Translational Approach in Monkey and Human | LILE, JOSHUA ANTHONY | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02383043
GET https://conductscience.org/api/trials/v1/NCT02383043/registered