Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DA-03746 | Other Grant/Funding Number | National Institute on Drug Abuse |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks.
Cannabis abuse and dependence are the most prevalent drug use disorders in the United States (Compton et al., 2004), yet little is known about the factors contributing to successful marijuana treatment. Previously, we have shown that cognitive impairments in patients treated for substance disorders are associated with premature treatment dropout. However, little is known about whether such impairments are the result of drug use per se. The objective of this within-subject study is to determine whether decision-making and risk-taking are affected by acute cannabis intoxication. The Balloon Analogue Risk Task (BART; Lejuez et al. 2002) assesses decision making in a context of increasing risk, and the Iowa Gambling Task (IGT; Bechara et al. 1994) tests the ability to balance immediate rewards against long-term negative consequences; both tasks have strong face validity for evaluating cognitive deficits that may contribute to poor treatment outcome. Research volunteers will be current marijuana smokers. Each will participate in three, 4-hour outpatient sessions in the Substance Use Research Center (SURC) in the Division of Substance Abuse at NYSPI. They will smoke a different strength marijuana cigarette (0.0, 1.98, 3.9% THC) in each session in counter-balanced order. After baseline data have been collected (risk taking and decision making behaviors, heart rate, blood pressure, mood scales, exhaled carbon monoxide), participants will take 3-6 puffs, 5 seconds in duration, from a National Institute on Drug Abuse (NIDA) marijuana cigarette. After smoking, we will repeatedly re-assess risk taking and decision making abilities with the BART and IGT. We will also measure subjective mood ratings, heart rate and blood pressure repeatedly for 180 minutes following smoking. This study is the first controlled investigation of the effects of smoked marijuana on both risk taking and decision making tasks. The data obtained will be used to guide treatment development for marijuana use disorders.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactive Marijuana (0, 1.8, or 3.9% THC) | Placebo Comparator | In this randomized, placebo-controlled study, every participant received all 3 treatment interventions in randomized order. Inactive marijuana (0% THC) served as a placebo comparator. Participants received an inactive marijuana cigarette (0% THC; provided by NIDA) in 1 of the 3 outpatient sessions in randomized order. |
|
| Active Marijuana | Experimental | In this randomized, placebo-controlled study, every participant received all 3 treatment interventions in randomized order. Participants received active marijuana cigarettes (1.8, or 3.9% THC; provided by NIDA) over 2 of 3 outpatient sessions in randomized order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactive Marijuana (0% THC) | Drug | Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making] | A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A-D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards. Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance. | 3 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.D. | New York State Psychiatric Institute | Principal Investigator |
| Efrat Aharonovich, Ph.D. | New York State Psyhciatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
Not provided
A total of 36 healthy research volunteers completed this three-session, within-subject outpatient study. Drug treatment was randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0%, Then 1.98%, Then 3.56% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| FG001 | 0%, Then 3.56%, Then 1.98% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| FG002 | 1.98%, Then 0%, Then 3.56% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| FG003 | 1.98%, Then 3.56%, Then 0% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| FG004 | 3.56%, Then 0%, Then 1.98% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| FG005 | 3.56%, Then 1.98%, Then 0% THC | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 36 participants completed the study. Baseline characteristics only available for the 36 completed participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Sample | A total of 36 participants completed the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making] | A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A-D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards. Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance. | All participants who completed the study (N=36) were included in the final analysis. | Posted | Mean | Standard Deviation | mean number of cards | 3 weeks |
3 weeks for each treatment and 1 week after receiving last treatment.
Safety population included all participants who received at least one intervention. Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inactive Marijuana (0%THC) | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney | New York State Psychiatric Institute | 646-774-6153 | mh235@cumc.columbia.edu |
Not provided
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind, placebo-controlled
|
| Low THC marijuana (1.8 %THC) | Drug | Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion. |
|
|
| High THC marijuana (3.9% THC) | Drug | Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion. |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Inactive Marijuana (0%THC) | Task performance for all 36 participants under placebo conditions. |
| OG001 | Low Dose Marijuana (1.8% THC) | Task performance for all 36 participants under low dose marijuana conditions. |
| OG002 | High Dose Marijuana (3.9% THC) | Task performance for all 36 participants under high dose marijuana conditions. |
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Low Dose Marijuana (1.8% THC) | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition. | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | High Dose Marijuana (3.9% THC) | A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition. | 0 | 36 | 0 | 36 | 0 | 36 |
Not provided
Not provided