Cocaine Dependence
Conditions
Brief summary
Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
Interventions
DRUGoxytocin
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
DRUGsaline
Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1\) General Inclusion /
Exclusion criteria
Inclusion Criteria 1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. 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 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. In addition, because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse and dependence will be included if they do not require medically supervised detoxification. Due to the high comorbidity of cocaine and marijuana dependence, individuals with marijuana dependence will be included. 3. Subjects must consent to random assignment. 4. Subjects must consent to outpatient admission to the CTRC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels | 0 minutes post 15 minute stress task | salivary cortisol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert Scale Rating of Subjective Stress | 0 minutes post 15 minute stress task | Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely' |
| Likert Scale Rating of Subjective Craving | 0 mintues post 15 minute stress task | Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. | 17 |
| Placebo saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Oxytocin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 16 Participants | 33 Participants |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Salivary Cortisol Levels
salivary cortisol
Time frame: 0 minutes post 15 minute stress task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Salivary Cortisol Levels | 0.18 mg/dl | Standard Deviation 0.09 |
| Placebo | Salivary Cortisol Levels | 0.22 mg/dl | Standard Deviation 0.09 |
Secondary
Likert Scale Rating of Subjective Craving
Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
Time frame: 0 mintues post 15 minute stress task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Likert Scale Rating of Subjective Craving | 3.35 units on a scale | Standard Deviation 4.03 |
| Placebo | Likert Scale Rating of Subjective Craving | 3.13 units on a scale | Standard Deviation 2.8 |
Secondary
Likert Scale Rating of Subjective Stress
Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
Time frame: 0 minutes post 15 minute stress task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Likert Scale Rating of Subjective Stress | 4.18 units on a scale | Standard Deviation 3.49 |
| Placebo | Likert Scale Rating of Subjective Stress | 4.25 units on a scale | Standard Deviation 2.93 |