Phase 2
N=23
Caffeine and Cocaine
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00733993 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Visual Analog Scale Subjective Rating of Drug Effects — 8.65; 9.85; 13.65; 10.43 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Caffeine 150 MG (Drug); Placebo (Drug); Amphetamine (Drug); Caffeine 300 MG (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale Subjective Rating of Drug Effects |
8.65; 9.85; 13.65; 10.43; 25.99; 32.54 | — |
| PRIMARY Systolic and Diastolic Blood Pressure |
115.64; 115.9; 117.36; 119.27; 120.18; 122.10 | — |
| PRIMARY Heart Rate |
66.10; 62.47; 61.33; 65.55; 63.08; 62.60 | — |
| PRIMARY Addiction Research Center Inventory Subjective Rating of Drug Effects |
3.87; 3.62; 3.52; 3.64; 1.95; 1.83 | — |
| PRIMARY Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects |
16.75; 20.25; 9.45; 11.37; 17.30; 20.73 | — |
| SECONDARY Probabalistic Feedback Selection Task |
0.56; 0.55; 0.56; 0.61; 0.54; 0.56 | — |
| SECONDARY Saliva Caffeine and Paraxanthine Levels |
1000; 510; 335; 983; 2715; 2895 | — |
Summary
This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.
Eligibility Criteria
Inclusion Criteria
- Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
- At least one cocaine positive urine during screening.
- Current regular consumption of caffeine.
- Female subjects: a negative pregnancy test.
Exclusion Criteria
- Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
- Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
- Substance dependence other than cocaine within the last 3 months.
- Positive breath alcohol.
- Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
- For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
- Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
- HIV positive.
- I.Q. below 70.
Data sourced from ClinicalTrials.gov (NCT00733993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.