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Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer

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ClinicalTrials.gov Identifier: NCT02383043
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Active Cocaine Users
Interventions Drug: Cocaine
Drug: Sustained Release d-Amphetamine
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo
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Cocaine choice during placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance

Placebo and Cocaine

Placebo and Sustained Release d-Amphetamine

Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance

Placebo and Cocaine

Placebo Sustained Release d-Amphetamine maintenance

Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance

Placebo and Cocaine

Placebo and Sustained Release d-Amphetamine

Period Title: Overall Study
Started 9 5 4
Completed 7 5 4
Not Completed 2 0 0
Arm/Group Title Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo Total
Hide Arm/Group Description

Cocaine choice during Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance

Placebo and Cocaine

Placebo and Sustained Release d-Amphetamine

Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance

Placebo and Cocaine

Placebo and Sustained Release d-Amphetamine

Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance

Placebo and Cocaine

Placebo and Sustained Release d-Amphetamine

Total of all reporting groups
Overall Number of Baseline Participants 7 5 4 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 4 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
5
 100.0%
4
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 4 participants 16 participants
Female
2
  28.6%
1
  20.0%
2
  50.0%
5
  31.3%
Male
5
  71.4%
4
  80.0%
2
  50.0%
11
  68.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 4 participants 16 participants
Non-Hispanic/Latino Black Female
1
  14.3%
1
  20.0%
0
   0.0%
2
  12.5%
Non-Hispanic/Latino White Female
1
  14.3%
0
   0.0%
2
  50.0%
3
  18.8%
Non-Hispanic/Latino Black Male
3
  42.9%
3
  60.0%
1
  25.0%
7
  43.8%
Non-Hispanic/Latino White Male
1
  14.3%
1
  20.0%
1
  25.0%
3
  18.8%
Hispanic/Latino Black Male
1
  14.3%
0
   0.0%
0
   0.0%
1
   6.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 4 participants 16 participants
7
 100.0%
5
 100.0%
4
 100.0%
16
 100.0%
1.Primary Outcome
Title The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Hide Description 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.
Time Frame 9 choice trials per cocaine dose level with each trial separated by 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 30 mg d-Amphetamine Placebo Treatment 60 mg d-Amphetamine
Hide Arm/Group Description:

Cocaine choice during 30 mg d-amphetamine maintenance

Placebo and Cocaine

Sustained Release d-Amphetamine

Cocaine choice during placebo maintenance

Placebo and Cocaine

Placebo

Cocaine choice during 60 mg d-amphetamine maintenance

Placebo and Cocaine

Sustained Release d-Amphetamine

Overall Number of Participants Analyzed 16 16 16
Mean (Standard Error)
Unit of Measure: cocaine choices
Placebo Cocaine 0.06  (0.06) 0.94  (0.35) 0.75  (0.36)
3 mg/70 kg Cocaine 0.88  (0.43) 2.50  (0.89) 0.56  (0.26)
10 mg/70 kg Cocaine 1.88  (0.50) 5.13  (0.93) 1.50  (0.51)
30 mg/70kg Cocaine 4.69  (0.89) 6.00  (0.99) 5.19  (0.95)
Time Frame 33 days per subject.
Adverse Event Reporting Description Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
 
Arm/Group Title Medical Safety Session Placebo 30 mg d-Amphetamine 60 mg d-Amphetamine
Hide Arm/Group Description Experimenter administered Placebo and Cocaine delivery. d-Amphetamine maintenance not yet initiated.

Cocaine choice during placebo d-Amphetamine maintenance

Placebo and Cocaine

Cocaine choice during 30 mg d-Amphetamine maintenance

Placebo and Cocaine

Cocaine choice during 60 mg d-Amphetamine maintenance

Placebo and Cocaine

All-Cause Mortality
Medical Safety Session Placebo 30 mg d-Amphetamine 60 mg d-Amphetamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/18 (0.00%)      0/17 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Medical Safety Session Placebo 30 mg d-Amphetamine 60 mg d-Amphetamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)      0/17 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medical Safety Session Placebo 30 mg d-Amphetamine 60 mg d-Amphetamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/18 (0.00%)      0/17 (0.00%)      1/17 (5.88%)    
Gastrointestinal disorders         
Nausea and vomiting * [1]  1/18 (5.56%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Chest pain * [2]  0/18 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Nausea and vomiting after smoking a cigarette following administration of cocaine doses during the medical safety session.
[2]
Chest pain after a session with placebo cocaine maintenance on 60 mg d-amphetamine. Cardiovascular monitoring revealed normal vital signs and heart rhythmicity. Pain determined to be musculoskeletal.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Joshua A. Lile, Ph.D.
Organization: University of Kentucky
Phone: 859-420-0503
Responsible Party: Joshua A. Lile, Ph.D., University of Kentucky
ClinicalTrials.gov Identifier: NCT02383043     History of Changes
Other Study ID Numbers: R01DA033364-02 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2015
First Posted: March 9, 2015
Results First Submitted: January 30, 2019
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019