Effects of Propranolol on Responses to Drug-Related Imagery Scripts
NCT ID: NCT00688805
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
40 participants
INTERVENTIONAL
2007-12-12
2013-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Relapse to drug abuse is thought to result, in many cases, from exposure to cues that trigger drug-related memories or emotional associations for example, the association between the sight of a crack pipe and a set of responses such as rapid heartbeat and desire for cocaine. This type of memory is reconsolidated (actively re-stored) each time it is reactivated; however, the reconsolidation process can be disrupted by the drug propranolol, which weakens the link between that memory and an emotional response.
* Propranolol is traditionally used to treat high blood pressure and other heart-related conditions. Researchers are interested in studying whether propranolol disrupts reconsolidation of drug-cued memories in individuals who are addicted to cocaine.
Objectives:
\- To examine whether propranolol can interfere with reconsolidation of cocaine-related memories and reduce cravings and drug use in substance abusers.
Eligibility:
\- Individuals between 18 and 55 years of age who are current cocaine users enrolled in a methadone treatment program.
Design:
* The study will involve four long sessions (visits 1, 4, 6, and 14) and 10 short sessions. The short visits will be for monitoring of participants use of drugs and alcohol; the longer visits will involve more tests and lab sessions. Participants will be randomized to either the propranolol or placebo group.
* The long sessions will involve the following procedures:
* An interview session to develop a personalized drug script/cue set.
* A two-hour intervention session with baseline measures, drug administration (propranolol or placebo), and two script-guided imagery sets. This is the only administration of propranolol during the study.
* Two follow-up test sessions, 1 and 5 weeks after the intervention session.
* Participants will make brief visits to our outpatient clinic for twice-weekly monitoring of ongoing drug use via urine screens and self-report, starting 1 week before the intervention session and ending 5 weeks later.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Relapse to drug abuse or addiction is thought to result, in many cases, from exposure to cues that elicit drug-related memories. The term memories is used here not in its everyday sense, but in a sense that corresponds more closely to emotional associations for example, the association between the sight of a crack pipe and a set of responses such as rapid heartbeat and desire for cocaine. Studies in rodents and humans show that this type of memory is reconsolidated (actively re-stored) each time it is reactivated, and that the reconsolidation process can be disrupted by propranolol. Such disruption does not erase the autobiographical memory of an event, but instead weakens the link between that memory and an emotional response. Human studies are needed to determine whether propranolol disrupts reconsolidation of drug-cued memories in addicted individuals; this would present a novel and exciting therapeutic possibility for preventing craving and relapse.
Objective
To examine whether administration of propranolol interferes with reconsolidation of cocaine-related memories and reduces cravings and drug use in substance abusers.
Study population
Up to 200 (60 evaluable) individuals maintained on methadone and using cocaine will be recruited from local treatment programs. The target enrollment will include 40% women and 60% minorities.
Experimental design and methods
Participants will be randomized to one of two groups: propranolol (40 mg, oral, immediate-release formulation) or placebo. The study will include four laboratory sessions: (1) An information-gathering session that includes an interview to obtain information for development of a personalized drug script/cue set. (2) A two-hour intervention session in which there will be baseline measures, drug administration (propranolol or placebo, double blind), and, starting 60 min after drug administration, two script-guided imagery sets. Cue-responsivity data will be collected, but the main purpose of the session is interventional. This will be the only administration of propranolol during the study. (3, 4) Two follow-up test sessions, 1 and 5 weeks after the intervention session; participants responses to re-exposure to the personalized drug script/cue set will be measured. In addition to attending the four laboratory sessions, participants will make brief visits to our outpatient clinic for twice-weekly monitoring of ongoing drug use via urine screens and self-report, starting 1 week before the intervention session and ending 5 weeks later.
Outcome measures
Outcome measures will include subjective ratings of drug craving, autonomic responses (heart rate, blood pressure, galvanic skin response), and cocaine and heroin use (urine drug screens and self-reported drug use).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Propranolol
40 mg given as a single oral administration in an opaque capsule
Arm 2
Placebo
matching capsule containing no active medication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Propranolol
40 mg given as a single oral administration in an opaque capsule
Placebo
matching capsule containing no active medication
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. \- Evidence of current cocaine use (self-report)
3. \- Minimum lifetime cocaine use of one year (self-report)
4. \- Minimum use of cocaine of once in the past 30 days (self-report)
5. \- Enrolled in methadone maintenance
Exclusion Criteria
2. \- History of: schizophrenia (or of any other DSM-IV psychotic disorder), anxiety disorders (e.g., panic disorder), or bipolar disorder.
3. \- Current major depressive disorder.
4. \- Current physical dependence on, or current abuse of, alcohol, benzodiazepines, or other sedative-hypnotic drugs.
5. \- Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
6. \- Pregnant; breast feeding.
7. \- Impaired hepatic function with AST or ALT greater than 5x the upper limit of normal.
8. \- Medical conditions that would contraindicate administration of propranolol (e.g., uncompensated congestive heart failure; pulmonary edema; asthma; COPD; history of severe allergic reactions (seasonal, environmental, food, medications, etc.); Raynaud s disease; second- or third-degree atrioventricular block; arrhythmias other than sinus arrhythmia; thyroid dysfunction; diabetes mellitus; renal impairment.
Per the American Thoracic Society (ATS), COPD Clinical assessment is based on medical history and physical examination. Although a complete examination is indicated for all patients, these two components are specifically important for patients with suspected COPD. (ATS \& ERS, 2004) Accordingly, if medical history and physical exam suggest possible COPD the participant will be forwarded for spirometry/pulmonary function tests to aid in the diagnosis.
9. \- Bradycardia (heart rate \< 60 bpm) on three consecutive readings.
10. \- Systolic blood pressure \< 100 mm Hg; diastolic blood pressure \< 60 mm Hg; on three consecutive readings.
11. \- Medications that could interact with propranolol either pharmacodynamically or pharmacokinetically to produce adverse effects. Such medication would include CNS depressants (e.g., barbiturates, benzodiazepines, other sedatives), antihypertensive medications (including nitrates), antiarrhythmic medications, antiseizure medications (dilantin), acetylcholinesterase inhibitors (e.g., donepezil, galantamine), aminoquinolines (antimalarial), antipsychotic medications, beta agonists, insulin, MAOIs, NSAIDs, rifamycin derivatives, rizatriptan, SSRIs, sulfonylureas, theophylline, pseudophedrine, phenylephrine, ephedrine, epinephrine, noriepinephrine, amphetamines, and some herbal supplements.
12. \- Current use of beta blockers for any medical condition.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenzie Preston, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Drug Abuse (NIDA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute on Drug Abuse
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Abduljawad KA, Langley RW, Bradshaw CM, Szabadi E. Effects of clonidine and diazepam on the acoustic startle response and on its inhibition by 'prepulses' in man. J Psychopharmacol. 1997;11(1):29-34. doi: 10.1177/026988119701100110.
Benschop RJ, Jacobs R, Sommer B, Schurmeyer TH, Raab JR, Schmidt RE, Schedlowski M. Modulation of the immunologic response to acute stress in humans by beta-blockade or benzodiazepines. FASEB J. 1996 Mar;10(4):517-24. doi: 10.1096/fasebj.10.4.8647351.
Berger SP, Hall S, Mickalian JD, Reid MS, Crawford CA, Delucchi K, Carr K, Hall S. Haloperidol antagonism of cue-elicited cocaine craving. Lancet. 1996 Feb 24;347(9000):504-8. doi: 10.1016/s0140-6736(96)91139-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
08-DA-N433
Identifier Type: -
Identifier Source: secondary_id
999908433
Identifier Type: -
Identifier Source: org_study_id