The Effect of Yohimbine on Cocaine Cue Reactivity

NCT00535002 | Completed Phase 2 Results

• 2 other identifiers: P50DA016511-1P50DA016511
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent individuals. In addition, there appears to be gender differences in determinants of relapse to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of the present study is to study the role of hormonal status on the response to cocaine-related cues with or without stress in cocaine-dependent women and men.

Conditions

Cocaine Related Disorders

Keywords

Cocaine Addiction; Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Cocaine Craving

  Cocaine-dependent participants were pre-treated with either yohimbine or placebo provided subjective ratings of cocaine craving immediately following cocaine cue exposure. The scale used was the Within Sessions Ratings Scales (Childress AR, McLellan AT, O'Brien CP (1986) Conditioned responses in a methadone population. A comparison of laboratory, clinic, and natural settings. Journal of Substance Abuse Treatment 3:173-179.) Craving was rated on a scale of 0-10 with 0 being Not At All and 10 being Extremely.

  Post cocaine cue exposure

Study Arms (8)

Cocaine Females, Yohimbine then Placebo

OTHER

Cocaine dependent females, received yohimbine day 1 and placebo day 2

Drug: Yohimbine; Drug: Placebo

Cocaine Females, Placebo the Yohimbine

OTHER

Cocaine dependent females, received placebo day 1 and yohimbine day 2

Drug: Yohimbine; Drug: Placebo

Cocaine Males, Yohimbine then Placebo

OTHER

Cocaine dependent males, received yohimbine day 1 and placebo day 2

Drug: Yohimbine; Drug: Placebo

Cocaine Males, Placebo thenYohimbine

OTHER

Cocaine dependent males, received placebo day 1 and yohimbine day 2

Drug: Yohimbine; Drug: Placebo

Control Females, Yohimbine then Placebo

OTHER

Non-dependent females, received yohimbine day 1 and placebo day 2

Drug: Yohimbine; Drug: Placebo

Control Females, Placebo then Yohimbine

OTHER

Non-dependent females, received placebo day 1 and yohimbine day 2

Drug: Yohimbine; Drug: Placebo

Control Males, Yohimbine then Placebo

OTHER

Non-dependent males, received yohimbine day 1 and placebo day 2

Drug: Yohimbine; Drug: Placebo

Control Males, Placebo then Yohimbine

OTHER

Non-dependent males, received placebo day 1 and yohimbine day 2

Drug: Yohimbine; Drug: Placebo

Interventions

Yohimbine DRUG

Participants were pre-treated with either yohimbine or placebo.

Cocaine Females, Placebo the Yohimbine; Cocaine Females, Yohimbine then Placebo; Cocaine Males, Placebo thenYohimbine; Cocaine Males, Yohimbine then Placebo; Control Females, Placebo then Yohimbine; Control Females, Yohimbine then Placebo; Control Males, Placebo then Yohimbine; Control Males, Yohimbine then Placebo

Placebo DRUG

Cocaine Females, Placebo the Yohimbine; Cocaine Females, Yohimbine then Placebo; Cocaine Males, Placebo thenYohimbine; Cocaine Males, Yohimbine then Placebo; Control Females, Placebo then Yohimbine; Control Females, Yohimbine then Placebo; Control Males, Placebo then Yohimbine; Control Males, Yohimbine then Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. Individuals with alcohol dependence will be excluded. However because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse will be included. Also, due to the high comorbidity of cocaine and marijuana dependence, and limited evidence that marijuana use affects HPA function, subjects with marijuana dependence will be included.
• Subjects with ADHD will be included. Because ADHD is commonly characterized by impulsivity, ADHD severity ratings will be determined and controlled for in data analysis.
• Subjects must consent to random assignment.
• Subjects must consent to outpatient admission to the CTRC and two overnight admissions to the Medical University Hospital.

You may not qualify if:

• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure (Woods et al., 1994).
• Women receiving depot medroxyprogesterone acetate as a form of birth control.
• Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
• Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.
• Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
• Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.
• Subjects with panic disorder, as yohimbine may precipitate panic attacks.
• Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.
• Subjects taking any psychotropic medications,antidepressants, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included.
• Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
• Subjects who are obese (BMI\>35) as this may interfere with hormonal status.
• Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.
• Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, alcohol, marijuana or cocaine as appropriate) within the past 60 days.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (1)

Medical University of South Carolina-GCRC

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. McRae-Clark
• Organization: Medical University of South Carolina

mcraeal@musc.edu

843-792-5216

Study Officials

• Kathleen T Brady, M.D., Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-03

Locations

US (1)