Cocaine DependencePhase 1NCT00688805
Effects of Propranolol on Responses to Drug-Related Imagery Scripts
A Phase 1 study testing Propranolol in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2007to 16 Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age between 18 and 55 years
- - Evidence of current cocaine use (self-report)
- - Minimum lifetime cocaine use of one year (self-report)
- - Minimum use of cocaine of once in the past 30 days (self-report)
- - Enrolled in methadone maintenance
Who cannot join
- - Allergy or hypersensitivity to propranolol or other beta blockers.
- - History of: schizophrenia (or of any other DSM-IV psychotic disorder), anxiety disorders (e.g., panic disorder), or bipolar disorder.
- - Current major depressive disorder.
- - Current physical dependence on, or current abuse of, alcohol, benzodiazepines, or other sedative-hypnotic drugs.
- - Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
- - Pregnant; breast feeding.
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- - Impaired hepatic function with AST or ALT greater than 5x the upper limit of normal.
- - 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.
- - Bradycardia (heart rate < 60 bpm) on three consecutive readings.
- - Systolic blood pressure < 100 mm Hg; diastolic blood pressure < 60 mm Hg; on three consecutive readings.
- - 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.
- - Current use of beta blockers for any medical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
- 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.
Read more
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.
Read the detailed description
Background
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
- Cocaine Dependence
- Being tested
- Propranolol, Placebo
- Keywords
- Propanolol, Substance Abuse, Craving, Imagery, Drug Cues, Cocaine
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
40 mg given as a single oral administration in an opaque capsule
PlaceboDrug
matching capsule containing no active medication
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Propranolol |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug craving
Measured: 1 hr
Secondary outcomes (1)
Galvanic skin response
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study start12 Dec 2007
- Primary completion16 Dec 2013
- Study completion16 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenzie Preston, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688805
- Sponsor's protocol ID
- 999908433
- Other IDs
- 08-DA-N433
- Status last verified
- 16 Dec 2013
- First submitted
- 30 May 2008
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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.
PubMed 9097890Benschop 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.
PubMed 8647351Berger 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.
PubMed 8596268
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propranolol on Responses to Drug-Related Imagery Scripts
- ClinicalTrials.gov ID
- NCT00688805
- Acronym / sponsor ID
- 999908433
- Conditions
- Cocaine Dependence
- Keywords
- Propanolol, Substance Abuse, Craving, Imagery, Drug Cues, Cocaine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 12 Dec 2007
- Primary completion
- 16 Dec 2013 (actual)
- Study completion
- 16 Dec 2013 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- 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
Background
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Propranolol |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (13 listed)
- - Allergy or hypersensitivity to propranolol or other beta blockers.
- - History of: schizophrenia (or of any other DSM-IV psychotic disorder), anxiety disorders (e.g., panic disorder), or bipolar disorder.
- - Current major depressive disorder.
- - Current physical dependence on, or current abuse of, alcohol, benzodiazepines, or other sedative-hypnotic drugs.
- - Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol40 mg given as a single oral administration in an opaque capsule | Drug | Arm 1 |
| Placebomatching capsule containing no active medication | Drug | Arm 2 |
Primary outcome
Drug craving
Time frame: 1 hr
1 secondary outcome
Galvanic skin response
Time frame: 1 hr
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 9097890Abduljawad 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.
- Background: PubMed 8647351Benschop 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.
- Background: PubMed 8596268Berger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenzie Preston, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propranolol in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug craving (time frame: 1 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00688805, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.