Marijuana DependencePhase 4NMWNCT01400243
Nicotine Patch for Marijuana Withdrawal
A Phase 4 study testing Nicotine in people with Marijuana Dependence, run by Southern Illinois University Carbondale at 1 site in United States.
Trial summary
The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2014
- Phase
- Phase 4
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Criteria include meeting DSM-IV criteria for current abuse or dependence on a substance other than MJ, nicotine, or caffeine, using psychoactive substances (other than MJ, alcohol, nicotine, \& caffeine) 6+ times/month, testing positive for stimulants, antidepressants, anxiolytics, and/or opiates (10-panel urine drug test), testing above a salivary cotinine concentration of 150 ng/ml during the initial screening, using creatinine or creatinine-containing supplements, testing positive for adulteration of urine samples, consuming more than 6 alcoholic drinks per day continuously for a month, mental disorders including bipolar disorder, schizophrenia, psychotic symptoms, currently, recently, or ever chronically at significant suicidal risk or experiencing violent thoughts or current major depression. Others that will be excluded include women who are pregnant, lactating, not taking precautions to avoid pregnancy, individuals with significant physical disorders or unstable physical disorders that may represent a severe untreated condition, such as hypertension, as well as those with less than a high school education or equivalent, primary language other than English, and those with significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University
Carbondale, Illinois, 62901
About this study
Official title: Nicotine for Marijuana Withdrawal
The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.
Read the detailed description
The aim of this proposal is to accurately assess the effects of TNP on MJ withdrawal symptoms across 15 days of biochemically confirmed MJ abstinence using a placebo-controlled, double-blind, randomly assigned treatment design, while closely monitoring any potential adverse effects, including changes in nicotine use and dependence.
To achieve these goals, 116 carefully screened cannabis-dependent individuals (58 female) will be randomly assigned to one of two doses (0 mg or 7mg nicotine) of TNP (transdermal nicotine patch) while they abstain from MJ for 15 days. Subjects will be administered a follow-up phone interview 30 days after the termination of treatment to assess the effects of nicotine-patch treatment on: 1) frequency of nicotine and tobacco smoking intake, 2) Fagerstrom Test of Nicotine Dependence (FTND)-assessed nicotine dependence, 3) new use of nicotine during the time since completion of the study, and 4) marijuana and other drug use patterns. Large financial contingencies will be used to provide a high degree of abstinence and study completion. This will be the first adequately powered study to assess the effects of TNP on MJ negative affect-related withdrawal symptoms and urges to use MJ. Withdrawal patterns and abstinence will be assessed in two groups of MJ-dependent individuals: 1) those who rarely or never smoke tobacco, and 2) those who smoke four or fewer tobacco cigarettes per day (very-light tobacco smokers). A stratified randomization method will be used to control for gender and tobacco-smoker status. It is hypothesized that MJ withdrawal symptoms will be less severe in the group assigned to the 7 mg patch than in the group assigned to the placebo. It is also hypothesized that individuals high in anxiety/neuroticism and those high in aggression/hostility will exhibit greater benefits from TNP than those low in these traits. Given that no gender differences were observed in our preliminary study, gender differences are not predicted. The over-the-counter availability, minimal abuse risks, and minimal adverse side-effects associated with TNP would make it an ideal and highly implementable treatment for MJ dependence if it can be demonstrated to be efficacious in reducing MJ withdrawal symptoms.
- Conditions
- Marijuana Dependence
- Being tested
- Nicotine, Placebo Patch
- Keywords
- Marijuana, Drug withdrawal symptoms, Nicotine
- Medical subject headings
- Marijuana Abuse, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Habitrol
Nicotine patch 7mg
Placebo PatchDrug
Also called Placebo patch from Rejuvenations Lab
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Placebo Patch | Placebo comparator | Placebo patch for 15-day quit period Receives: Drug: Placebo Patch |
| Nicotine Patch | Active comparator | 7 mg Habitrol nicotine patch-15 day quit period Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.
Measured: 16 days (prequit baseline and 15 days of abstinence)
Marijuana Withdrawal Questionnaire (MWC) Total Score
The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal.
Measured: 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)
POMS Vigor/Positive Affect (PA)
Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from "0" (no vigor) to "32" (maximally high vigor score).
Measured: 16 days (baseline through day 15 of treatment)
Secondary outcomes (6)
Patch Guess and Attributions Questionnaire
The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.
Measured: Day 15 of abstinence
Systolic Blood Pressure (SBP)
Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.
Measured: From baseline to Day 15 of abstinence
Tobacco and Nicotine Intake
Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.
Measured: Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.
Measured: across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence
Heart Rate
Heart rate measured during laboratory assessment sessions.
Measured: Baseline through Day 15 of abstinence
Diastolic Blood Pressure (DBP)
Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.
Measured: From baseline to Day 15 of abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionJun 2014
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Carbondale
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David G Gilbert, PhD, Principal investigator, Southern Illinois University Carbondale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400243
- Sponsor's protocol ID
- NIH/NIDA 1R01DA031006 - 01
- Other IDs
- R01DA031006
- Acronym
- NMW
- Status last verified
- Apr 2015
- First submitted
- 21 Mar 2011
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gilbert DG, Rabinovich NE, McDaniel JT. Nicotine patch for cannabis withdrawal symptom relief: a randomized controlled trial. Psychopharmacology (Berl). 2020 May;237(5):1507-1519. doi: 10.1007/s00213-020-05476-1. Epub 2020 Feb 7.
PubMed 32034447
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine for Marijuana Withdrawal
- ClinicalTrials.gov ID
- NCT01400243
- Acronym / sponsor ID
- NMW / NIH/NIDA 1R01DA031006 - 01
- Conditions
- Marijuana Dependence
- Keywords
- Marijuana, Drug withdrawal symptoms, Nicotine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Southern Illinois University CarbondaleUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 30 Apr 2015
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 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.
Detailed description
The aim of this proposal is to accurately assess the effects of TNP on MJ withdrawal symptoms across 15 days of biochemically confirmed MJ abstinence using a placebo-controlled, double-blind, randomly assigned treatment design, while closely monitoring any potential adverse effects, including changes in nicotine use and dependence.
To achieve these goals, 116 carefully screened cannabis-dependent individuals (58 female) will be randomly assigned to one of two doses (0 mg or 7mg nicotine) of TNP (transdermal nicotine patch) while they abstain from MJ for 15 days. Subjects will be administered a follow-up phone interview 30 days after the termination of treatment to assess the effects of nicotine-patch treatment on: 1) frequency of nicotine and tobacco smoking intake, 2) Fagerstrom Test of Nicotine Dependence (FTND)-assessed nicotine dependence, 3) new use of nicotine during the time since completion of the study, and 4) marijuana and other drug use patterns. Large financial contingencies will be used to provide a high degree of abstinence and study completion. This will be the first adequately powered study to assess the effects of TNP on MJ negative affect-related withdrawal symptoms and urges to use MJ. Withdrawal patterns and abstinence will be assessed in two groups of MJ-dependent individuals: 1) those who rarely or never smoke tobacco, and 2) those who smoke four or fewer tobacco cigarettes per day (very-light tobacco smokers). A stratified randomization method will be used to control for gender and tobacco-smoker status. It is hypothesized that MJ withdrawal symptoms will be less severe in the group assigned to the 7 mg patch than in the group assigned to the placebo. It is also hypothesized that individuals high in anxiety/neuroticism and those high in aggression/hostility will exhibit greater benefits from TNP than those low in these traits. Given that no gender differences were observed in our preliminary study, gender differences are not predicted. The over-the-counter availability, minimal abuse risks, and minimal adverse side-effects associated with TNP would make it an ideal and highly implementable treatment for MJ dependence if it can be demonstrated to be efficacious in reducing MJ withdrawal symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Patch | Placebo comparator | Drug: Placebo PatchPlacebo patch for 15-day quit period |
| Nicotine Patch | Active comparator | Drug: Nicotine7 mg Habitrol nicotine patch-15 day quit period |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Criteria include meeting DSM-IV criteria for current abuse or dependence on a substance other than MJ, nicotine, or caffeine, using psychoactive substances (other than MJ, alcohol, nicotine, \& caffeine) 6+ times/month, testing positive for stimulants, antidepressants, anxiolytics, and/or opiates (10-panel urine drug test), testing above a salivary cotinine concentration of 150 ng/ml during the initial screening, using creatinine or creatinine-containing supplements, testing positive for adulteration of urine samples, consuming more than 6 alcoholic drinks per day continuously for a month, mental disorders including bipolar disorder, schizophrenia, psychotic symptoms, currently, recently, or ever chronically at significant suicidal risk or experiencing violent thoughts or current major depression. Others that will be excluded include women who are pregnant, lactating, not taking precautions to avoid pregnancy, individuals with significant physical disorders or unstable physical disorders that may represent a severe untreated condition, such as hypertension, as well as those with less than a high school education or equivalent, primary language other than English, and those with significant cognitive impairment.
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 |
|---|---|---|
| NicotineAlso: HabitrolNicotine patch 7mg | Drug | Nicotine Patch |
| Placebo PatchAlso: Placebo patch from Rejuvenations LabPlacebo patch | Drug | Placebo Patch |
Primary outcome
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
Time frame: 16 days (prequit baseline and 15 days of abstinence)
POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.
Marijuana Withdrawal Questionnaire (MWC) Total Score
Time frame: 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)
The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal.
POMS Vigor/Positive Affect (PA)
Time frame: 16 days (baseline through day 15 of treatment)
Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from "0" (no vigor) to "32" (maximally high vigor score).
6 secondary outcomes
Patch Guess and Attributions Questionnaire
Time frame: Day 15 of abstinence
Systolic Blood Pressure (SBP)
Time frame: From baseline to Day 15 of abstinence
Tobacco and Nicotine Intake
Time frame: Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Time frame: across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence
Heart Rate
Time frame: Baseline through Day 15 of abstinence
Diastolic Blood Pressure (DBP)
Time frame: From baseline to Day 15 of abstinence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32034447Gilbert DG, Rabinovich NE, McDaniel JT. Nicotine patch for cannabis withdrawal symptom relief: a randomized controlled trial. Psychopharmacology (Berl). 2020 May;237(5):1507-1519. doi: 10.1007/s00213-020-05476-1. Epub 2020 Feb 7.
Related trials for Marijuana Dependence
Not yet recruitingEarly Phase 1
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
Cannabis Dependence
Not yet recruitingPhase 2
Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
Recruiting
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Psychotic Disorders, Cannabis Use Disorder
Not yet recruiting
Mobile Application-Based Interventions for Cannabis Use in Young Adults With First Episode Psychosis
First Episode Psychosis (FEP), Psychosis
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.
David G Gilbert, PhD principal investigator
Southern Illinois University Carbondale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine in people with Marijuana Dependence, run by Southern Illinois University Carbondale 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 0 inclusion and 1 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 30 Apr 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Apr 2015). 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?
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) (time frame: 16 days (prequit baseline and 15 days of abstinence)). The study lists 3 primary outcomes in all. 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 NCT01400243, 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 30 Apr 2015.