A Phase 2 interventional study of Guanfacine and Modafinil in Cocaine Related Disorders, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-06-04.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Other
Stressful situations and cues associated with cocaine can lead to craving in cocaine dependent individuals. The purpose of this study is to determine whether guanfacine or modafinil are effective in reducing stress and cue induced craving in cocaine dependent individuals.
Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. This is a randomized, double-blind, placebo-controlled study evaluating the effects of either guanfacine (Tenex) or modafinil (Provigil) on stress and cue induced craving in cocaine dependent individuals. Cocaine dependence will be assessed in adults (ages 18-65) as defined by DSM-IV criteria. If the subject signs the consent form, meets the study criteria and does not meet the exclusion criteria they will be included in the study. Subjects will report to the General Clinical Research Center (GCRC) at the Medical University of South Carolina (MUSC), for an outpatient visit and will receive their first dose of study medication. The following day subjects will return to the GCRC and admitted for the duration of the study (two days and one night). There will be a one-week and a one-month follow-up visit. Subjects will be randomly assigned to one of two treatment groups (guanfacine or placebo). Each subject will also be randomly assigned to either a stress or no-stress subgroup. On the test day (day 3) subjects in the stress group will be asked to perform a speech and a math problem in front of an audience (Trier Social Stress Test, TSST), while the no-stress group will be asked to sit quietly and read. Following these tasks, each subject will be exposed to neutral (control) cues and immediately afterwards the subjects will be exposed to cocaine cues (cocaine paraphernalia). Craving/mood, physiological activity, and endocrine responses, will be assessed at pre-set intervals throughout the testing procedure. The cue reactivity protocol will be repeated on the one-week follow-up visit.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 109 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) during the GCRC admission.
Because of the high comorbidity of alcohol and marijuana use and cocaine dependence, individuals meeting dependence for alcohol and marijuana will be included. Individuals requiring medical detox from alcohol will be excluded.
Subjects must consent to random assignment to stress vs. no stress and drug treatment conditions.
Exclusion Criteria:
Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. Modafinil inhibits metabolism of steroidal contraceptives via CYP3A4 and can reduce the effectiveness of this type of birth control, female subjects must use one of the following methods of birth control: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular (including but not limited to left ventricular hypertrophy (unless a cardiologist deems that it is not clinically significant), mitral valve prolapse, left bundle branch block, myocardial infarction, and angina), pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect HPA axis function.
Subjects with any liver function test (LFTs) of greater than two times normal, as compromised liver function can interfere with HPA axis activity (Williams and Dluhy 1987) and may affect drug metabolism.
Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect HPA axis function.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with HPA function.
Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in HPA axis function.
Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with HPA axis function within one month of the time of testing.
Subjects taking any psychotropic medications, opiates or opiate antagonists because these may affect HPA axis function.Participants taking SSRI's will be included.
Subjects required to take medications that could adversely interact with study medications, including, but not limited to, azole type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine. Any medications that induce or inhibit CYP3A4 pathways are excluded, as modafinil is metabolized through this enzyme system.
Subjects with any acute illness or fever as this may affect HPA axis activity. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
Subjects who are grossly obese (BMI > 39), as this may interfere with HPA axis function.
Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to the stress task procedure.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.
Participants received placebo for 2 days. modafinil on the third day and participated in the TRIER social stress task on the third day.
Drug: Modafinil
Participants received placebo for 2 days. modafinil on the third day and did not participate in the TRIER social stress task on the third day.
Drug: Modafinil
Participants received guanfacine for 3 days and participated in the TRIER social stress task on the third day.
Drug: Guanfacine
Participants received guanfacine for 3 days and did not participate in the TRIER social stress task on the third day.
Drug: Guanfacine
Participants received placebo for 3 days and participated in the TRIER social stress task on the third day.
Drug: Placebo
Participants received placebo for 3 days and did not participate in the TRIER social stress task on the third day.
Drug: Placebo
Cocaine Craving
Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.
Time frame: Post Trier social stress task + Cocaine Cue 2:30 pm
Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure
Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.
Time frame: Immediately following trier + cocaine cue exposure
Participants were recruited between April 2008 and May 2012. Participants were primarily recruited through newspaper and television advertisements and respondent driven sampling. All study procedures took place at the Medical University of South Carolina.
| Milestone | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress |
|---|---|---|---|---|---|---|
| Started | 13 | 12 | 26 | 24 | 15 | 19 |
| Completed | 13 | 11 | 23 | 21 | 13 | 16 |
| Not completed | 0 | 1 | 3 | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 3 | 3 | 2 | 3 |
Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.
| units on a scale | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress |
|---|---|---|---|---|---|---|
| Cocaine Craving | 3.08 ± 3.59 | 4.36 ± 2.84 | 1.54 ± 3.06 | 3.13 ± 3.49 | 1.8 ± 2.8 | 2.11 ± 2.4 |
Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.
| mcg/dl | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress |
|---|---|---|---|---|---|---|
| Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | 12.55 ± 3.27 | 11.69 ± 5.57 | 13.19 ± 5.36 | 9.06 ± 2.19 | 12.42 ± 3.95 | 8.94 ± 2.48 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modafinil/Stress | — | 0/13 (0%) | 0/13 (0%) |
| Modafinil/No Stress | — | 0/12 (0%) | 0/12 (0%) |
| Guanfacine/Stress | — | 0/26 (0%) | 0/26 (0%) |
| Guanfacine/No Stress | — | 0/24 (0%) | 0/24 (0%) |
| Placebo/Stress | — | 0/15 (0%) | 0/15 (0%) |
| Placebo/No Stress | — | 0/10 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 26 | 24 | 15 | 19 | 109 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress | Total |
|---|---|---|---|---|---|---|---|
| Mean | 42.46 ± 8.03 | 38.5 ± 10.49 | 41 ± 10.05 | 40.92 ± 9.55 | 40.2 ± 9.13 | 44 ± 8.6 | 41.41 ± 9.28 |
| Sex: Female, Male(Participants) | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 3 | 1 | 4 | 3 | 5 | 19 |
| Male | 10 | 9 | 25 | 20 | 12 | 14 | 90 |
| Region of Enrollment(participants) | Modafinil/Stress | Modafinil/No Stress | Guanfacine/Stress | Guanfacine/No Stress | Placebo/Stress | Placebo/No Stress | Total |
|---|---|---|---|---|---|---|---|
| United States | 13 | 12 | 26 | 24 | 15 | 19 | 109 |
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Medical University of South Carolina