Marijuana DependencePhase 2NCT00373295
Effect of Baclofen on Marijuana Withdrawal and Relapse
A Phase 2 study testing Baclofen and Marijuana in people with Marijuana Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Baclofen and Marijuana
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
- Able to perform study procedures
- 21-45 years of age
- Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Who cannot join
- Current, repeated illicit drug use (other than marijuana)
- Presence of significant medical illness(e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory clinically significant laboratory abnormalities)
- History of heart disease
- Request for drug treatment
- Current parole or probation
- Pregnancy or current lactation
Show all 9Show fewer
- Recent history of significant violent behavior
- Major current Axis I psychopathology(e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
- Current use of any prescription or over-the-counter medication
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
Read the detailed description
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006). Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (Akhondzadeh et al., 2000; Addolorato et al., 2000). The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. Further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.
- Conditions
- Marijuana Dependence
- Being tested
- Baclofen, Marijuana, Placebo
- Keywords
- Baclofen, Marijuana Dependence, Marijuana Withdrawal
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called Lioresal
Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
MarijuanaDrug
Also called cannabis
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Baclofen 60 mg, Placebo, Baclofen 90 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
| Baclofen 90 mg, Placebo, Baclofen 60 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
| Baclofen 60 mg, Baclofen 90 mg, Placebo | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
| Baclofen 90 mg, Baclofen 60 mg, Placebo | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
| Placebo, Baclofen 90 mg, Baclofen 60 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
| Placebo, Baclofen 60 mg, Baclofen 90 mg | Experimental | Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).
Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. Receives: Drug: Baclofen; Drug: Marijuana; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase
This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke.
Over each 3 day period, the puffs chosen by each participant is averaged for a single value.
Measured: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marijuana 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Margaret Haney, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373295
- Sponsor's protocol ID
- 5232
- Other IDs
- 5P50DA009236
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2006
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Haney M, Hart CL, Vosburg SK, Comer SD, Reed SC, Cooper ZD, Foltin RW. Effects of baclofen and mirtazapine on a laboratory model of marijuana withdrawal and relapse. Psychopharmacology (Berl). 2010 Aug;211(2):233-44. doi: 10.1007/s00213-010-1888-6. Epub 2010 Jun 3.
PubMed 20521030
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baclofen on Marijuana Withdrawal and Relapse
- ClinicalTrials.gov ID
- NCT00373295
- Acronym / sponsor ID
- 5232
- Conditions
- Marijuana Dependence
- Keywords
- Baclofen, Marijuana Dependence, Marijuana Withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
Detailed description
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006). Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (Akhondzadeh et al., 2000; Addolorato et al., 2000). The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. Further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Baclofen 60 mg, Placebo, Baclofen 90 mg | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
| Baclofen 90 mg, Placebo, Baclofen 60 mg | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
| Baclofen 60 mg, Baclofen 90 mg, Placebo | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
| Baclofen 90 mg, Baclofen 60 mg, Placebo | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
| Placebo, Baclofen 90 mg, Baclofen 60 mg | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
| Placebo, Baclofen 60 mg, Baclofen 90 mg | Experimental | Drug: Baclofen, Drug: Marijuana, Drug: PlaceboBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
- Able to perform study procedures
- 21-45 years of age
- Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Key exclusion criteria (9 listed)
- Current, repeated illicit drug use (other than marijuana)
- Presence of significant medical illness(e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory clinically significant laboratory abnormalities)
- History of heart disease
- Request for drug treatment
- Current parole or probation
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 |
|---|---|---|
| BaclofenAlso: LioresalBaclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). | Drug | Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 90 mg, Baclofen 90 mg, Baclofen 60 mg, Placebo, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 90 mg, Baclofen 60 mg |
| MarijuanaAlso: cannabisMarijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use. | Drug | Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 90 mg, Baclofen 90 mg, Baclofen 60 mg, Placebo, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 90 mg, Baclofen 60 mg |
| Placebo | Drug | Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 90 mg, Baclofen 90 mg, Baclofen 60 mg, Placebo, Baclofen 90 mg, Placebo, Baclofen 60 mg, Placebo, Baclofen 60 mg, Baclofen 90 mg, Placebo, Baclofen 90 mg, Baclofen 60 mg |
Primary outcome
Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase
Time frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)
This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20521030Haney M, Hart CL, Vosburg SK, Comer SD, Reed SC, Cooper ZD, Foltin RW. Effects of baclofen and mirtazapine on a laboratory model of marijuana withdrawal and relapse. Psychopharmacology (Berl). 2010 Aug;211(2):233-44. doi: 10.1007/s00213-010-1888-6. Epub 2010 Jun 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.
Margaret Haney, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baclofen and Marijuana in people with Marijuana Dependence, run by New York State Psychiatric Institute 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 May 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase (time frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)). 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 NCT00373295, which also lists 1 linked publication.
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 10 May 2017.